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1.
Nat Commun ; 12(1): 708, 2021 01 29.
Artículo en Inglés | MEDLINE | ID: mdl-33514724

RESUMEN

We report the development of a platform of dual targeting Fab (DutaFab) molecules, which comprise two spatially separated and independent binding sites within the human antibody CDR loops: the so-called H-side paratope encompassing HCDR1, HCDR3 and LCDR2, and the L-side paratope encompassing LCDR1, LCDR3 and HCDR2. Both paratopes can be independently selected and combined into the desired bispecific DutaFabs in a modular manner. X-ray crystal structures illustrate that DutaFabs are able to bind two target molecules simultaneously at the same Fv region comprising a VH-VL heterodimer. In the present study, this platform is applied to generate DutaFabs specific for VEGFA and PDGF-BB, which show high affinities, physico-chemical stability and solubility, as well as superior efficacy over anti-VEGF monotherapy in vivo. These molecules exemplify the usefulness of DutaFabs as a distinct class of antibody therapeutics, which is currently being evaluated in patients.


Asunto(s)
Anticuerpos Biespecíficos/farmacología , Neovascularización Coroidal/tratamiento farmacológico , Desarrollo de Medicamentos/métodos , Fragmentos Fab de Inmunoglobulinas/farmacología , Ingeniería de Proteínas , Secuencia de Aminoácidos/genética , Animales , Anticuerpos Biespecíficos/genética , Anticuerpos Biespecíficos/uso terapéutico , Anticuerpos Biespecíficos/ultraestructura , Becaplermina/antagonistas & inhibidores , Sitios de Unión de Anticuerpos/genética , Cristalografía por Rayos X , Modelos Animales de Enfermedad , Relación Dosis-Respuesta a Droga , Humanos , Fragmentos Fab de Inmunoglobulinas/genética , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Fragmentos Fab de Inmunoglobulinas/ultraestructura , Concentración 50 Inhibidora , Inyecciones Intravítreas , Masculino , Modelos Moleculares , Prueba de Estudio Conceptual , Conformación Proteica , Ratas , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
2.
JAMA ; 324(23): 2383-2395, 2020 12 15.
Artículo en Inglés | MEDLINE | ID: mdl-33320223

RESUMEN

Importance: Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown. Objective: To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy. Design, Setting, and Participants: Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020. Interventions: Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria. Main Outcomes and Measures: The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years. Results: Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept. Conclusions and Relevance: Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation. Trial Registration: ClinicalTrials.gov Identifier: NCT02858076.


Asunto(s)
Inhibidores de la Angiogénesis/administración & dosificación , Retinopatía Diabética/complicaciones , Fotocoagulación , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Retina/cirugía , Vitrectomía , Hemorragia Vítrea/tratamiento farmacológico , Hemorragia Vítrea/cirugía , Anciano , Inhibidores de la Angiogénesis/efectos adversos , Extracción de Catarata , Intervalos de Confianza , Femenino , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Proteínas Recombinantes de Fusión/efectos adversos , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual , Vitrectomía/efectos adversos , Hemorragia Vítrea/etiología
3.
Brasília; CONITEC; nov. 2020.
No convencional en Portugués | BRISA/RedTESA | ID: biblio-1145539

RESUMEN

CONTEXTO: O edema macular diabético (EMD) é a principal alteração responsável por perda irreversível de acuidade visual em pacientes com diabetes mellitus (DM) que desenvolveram retinopatia diabética (RD). O EMD é caracterizado por inchaço na região central do olho resultado da ruptura da barreira sanguínea-retiniana e do acúmulo de líquido nas camadas intrarretinianas da mácula. A prevenção primária do EMD é o manejo ideal da doença, considerando a associação direta da prevalência do diabetes e da RD. As estratégias de tratamento consistem inicialmente no controle sistêmico da glicemia, da hemoglobina glicada (HbA1c), de lipídeos séricos, da função renal, estabilização da pressão sanguínea e controle do índice de massa corporal, associado à prática de exercícios físicos e alimentação adequada. O estágio da doença é determinante para a escolha do método de tratamento e o sucesso do tratamento é avaliado pela acuidade visual, pelo estadiamento da classificação da RD e pela análise dos exames complementares. Atualmente a terapia considerada padrão-ouro no tratamento do EMD consiste no uso do fator de crescimento endotelial anti-vascular (antiVEGF), mas em caso de insucesso terapêutico o emprego de corticoides em forma de implantes de liberação controlada tem sido utilizado. Pergunta: O uso do implante biodegradável de dexametasona (Ozurdex®) é eficaz, seguro e custo-efetivo para o tratamento de pacientes adultos com EMD, que falham à terapia com agente anti-VEGF? Evidências científicas: Dez publicações (uma revisão sistemática, dois ensaios clínicos e sete estudos observacionais) foram apresentados no relatório. De acordo com a metanálise, de qualidade metodológica moderada, há um ganho de 20 letras na BCVA (melhor acuidade visual corrigida) de pacientes tratados com o implante biodegradável de dexametasona, após um seguimento médio de avaliação de seis meses. A maioria dos estudos observacionais apontam melhora da BCVA em relação ao baseline do estudo. Os ensaios clínicos apresentaram um risco de viés moderado e um deles descreveu os achados anatômicos do estudo MEAD, avaliando as principais alterações morfológicas em relação ao baseline da ESCR, volume macular, área de espessamento da retina, vazamento macular, perda capilar macular e gravidade da retinopatia diabética. O implante de dexametasona atrasou o tempo de início da progressão do EMD em ± 12 meses, o que ao final do estudo, reduziu a espessura do subcampo central da retina (ESCR) em média 117,3 e 127,8 m nos grupos tratados com dexametasona versus 62,1 m nos olhos tratados com simulação (tratamentos p <0,001 vs, simulação). Entre os desfechos secundários avaliados estão: aumento da PIO, alterações da EFC, ESC e EMC, além de alterações do grau de retinopatia diabética. Os principais eventos adversos relatados em pacientes sob tratamento foram: descolamento de retina, inflamação da câmara anterior; dor ocular; queratite ou opacidade vítrea; e insurgência da catarata. AVALIAÇÃO ECONÔMICA: Foi conduzido um estudo de custo-efetividade e análises de sensibilidade univariada e probabilística. O tratamento com o implante biodegradável de dexametasona foi comparado com um procedimento simulado, ou não tratamento, num horizonte temporal de três anos. Para a indicação proposta, a incorporação da dexametasona resultaria em uma razão de custo-efetividade incremental (RCEI) estimada de R$ 54.568,99 por paciente e inclui custos de aquisição do medicamento, de administração, além de custos com visitas e de avaliação de eventos adversos. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: Dois cenários foram avaliados para estimar o impacto orçamentário (AIO) da incorporação da dexametasona. O cenário base foi representado por um impacto total de R$ 1,76 bilhões em uma estimativa epidemiológica e um total de R$ 159,61 milhões em uma estimativa por demanda aferida, enquanto o cenário por protocolo foi representado por uma economia acumulada total de R$ 39,11 milhões em uma estimativa epidemiológica e R$ 3,50 milhões em uma estimativa por demanda aferida, ambos os cenários em um horizonte temporal de 5 anos. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foi detectada uma tecnologia, a fluocinolona acetonida, também um corticoide cuja via de administração é a mesma do implante biodegradável de dexametasona. Os estudos sobre a tecnologia atualmente estão em fase 4. Além disso, foi detectado no horizonte o medicamento aganirsen, um oligonucleotídeo, inibidor do gene IRS1, que está em fase 2 de pesquisa clínica para a indicação. Considerações: A evidência disponível é baseada em estudos clínicos randomizados e estudos observacionais que comparam o período pré-dexametasona e pós-dexametasona. Comparada ao procedimento simulado a dexametasona demonstrou melhora dos desfechos observados (BCVA, EFC, PIO, ESC, EMC, morfologia da retina, alterações no grau de RD e segurança), no entanto, a qualidade das evidências foi considerada baixa. Limitações importantes também foram identificadas na ACE e na AIO, indicando provável superestimação dos valores no âmbito no SUS. DECISÃO PRELIMINAR da Conitec: Diante do exposto, a Conitec, em sua 89ª reunião ordinária, realizada no dia 05 de agosto de 2020, deliberou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar desfavorável à incorporação no SUS do implante biodegradável de dexametasona para tratamento de pacientes com edema macular diabético não responsivos à terapia prévia com anti-VEGF. Considerou-se que as evidências apresentadas são insuficientes para os desfechos analisados, visto baixo nível de certeza apresentado. Além disso, do ponto de vista econômico, o uso de parâmetro inadequado no modelo ocorreu por parte do demandante, pois a dexametasona tem indicação apenas para pacientes não responsivos à terapia prévia com antiangiogênicos, dessa forma não cabe a comparação dos custos com o medicamento aflibercepte, considerando que não são tecnologias substitutas. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: A Consulta Pública nº 50/2020 foi realizada entre os dias 15/09/2020 a 05/10/2020. Foram recebidas 400 contribuições, sendo 152 pelo formulário para contribuições técnico-científicas e 248 pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. Dentre as 152 contribuições técnico-científicas, apenas 05 foram analisadas, pois 147 se tratavam de duplicatas, contribuições em branco, desprovidas de teor científico ou que tratavam de experiência ou opinião. As 05 contribuições consideradas para análise discordaram da recomendação preliminar da Conitec, tendo como justificativas: rápida resposta terapêutica da tecnologia, melhor responsividade em comparação à terapia com antiVEGF, bons resultados clínicos em casos de oclusões vasculares, olhos fácicos e uveítes inflamatórias, opção terapêutica em caso de contraindicação aos anti-VEGF ou dificuldade de seguimento. Dentre as 248 contribuições de experiência ou opinião recebidas, apenas 123 foram analisadas, pois 125 se tratavam de duplicatas ou contribuições em branco. Dentre as 123 analisadas, 105 discordaram da recomendação preliminar da Conitec, tendo como argumentações: o implante de dexametasona se trata de única terapia corticoide pós falha terapêutica aos anti-VEGF, pois o aumento de citocinas, em alguns casos, só são controladas pelo corticoide; o implante ser menos oneroso que o custo social quando há perda irreversível de visão dos pacientes; e restrição de uso, no SUS, de um medicamento já disponível no rol de procedimentos da Agência Nacional de Saúde Suplementar (ANS). O demandante e fabricante da tecnologia enviou nova proposta de preço para incorporação com 25% de desconto, junto à nova análise de custo-efetividade e impacto orçamentário, que foram apresentados aos membros do plenário. Além desta, outras contribuições analisadas foram importantes para a complementação do relatório, especialmente por trazer as expectativas de adesão ao procedimento, por profissionais e pacientes. RECOMENDAÇÃO FINAL: Os membros do plenário presentes na 92ª reunião ordinária da Conitec, no dia 04 de novembro de 2020, deliberaram, por unanimidade, recomendar a não incorporação, no SUS, do implante biodegradável de dexametasona para tratamento de pacientes com edema macular diabético não responsivos à terapia prévia com antiVEGF. Foi considerado que ainda há alguns aspectos não esclarecidos sobre a prática clínica no cuidado do EMD, como o limiar de ineficácia ou insucesso terapêutico com anti-VEGF e que faltam evidências científicas que indiquem se a tecnologia avaliada seria substitutiva para os anti-VEGF ou se deveria ser criada uma segunda linha para o cuidado do EMD. Reiterou-se que as evidências avaliadas no relatório técnico não foram consideradas robustas o suficiente para a tomada de decisão em favor da incorporação do implante biodegradavel de dexametasona em casos de ineficácia terapêutica com anti-VEGF, que foi a proposta apresentada pelo demandante. Ademais, não foram adicionadas na CP referências que alterassem a análise das evidências apresentadas no relatório preliminar. Foi assinado o Registro de Deliberação nº 570/2020. DECISÃO: Não incorporar o implante biodegradável de dexametasona no tratamento do edema macular diabético em pacientes não responsivos à terapia prévia com anti-VEGF, no âmbito do Sistema Único de Saúde - SUS, conforme Portaria nº 58, publicada no Diário Oficial da União nº 228, seção 1, página 716, em 1º de dezembro de 2020.


Asunto(s)
Humanos , Dexametasona/uso terapéutico , Edema Macular/tratamiento farmacológico , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Diabetes Mellitus/fisiopatología , Evaluación de la Tecnología Biomédica , Sistema Único de Salud , Brasil , Análisis Costo-Beneficio/economía
4.
Graefes Arch Clin Exp Ophthalmol ; 258(12): 2621-2628, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33009973

RESUMEN

PURPOSE: To estimate the impact of delayed care during the coronavirus disease 2019 (COVID-19) pandemic on the outcomes of patients with neovascular age-related macular degeneration (AMD). METHODS: Consecutive patients with diagnosis of neovascular AMD were consecutively enrolled between March 9, 2020, and June 12, 2020, (during and immediately after the Italian COVID-19 quarantine). During the inclusion (or pandemic) visit (V0), patients received a complete ophthalmologic evaluation, including optical coherence tomography (OCT). Best-corrected visual acuity (BCVA) and OCT findings from the two preceding visits (V-1 and V-2) were compared with data at V0. RESULTS: One-hundred patients (112 eyes) were enrolled in this study. The time interval between following visits was 110.7 ± 37.5 days within V0 and V-1 and 80.8 ± 39.7 days within V-1 and V-2, respectively (P < 0.0001). BCVA was statistically worse at the V0 visit as compared with the immediately preceding (V-1) visit (0.50 ± 0.43 LogMAR and 0.45 ± 0.38 LogMAR at the V0 and V-1 visits, respectively; P = 0.046). On structural OCT, 91 out of 112 (81.2%) neovascular AMD eyes displayed the evidence of exudative disease activity at the V0 visit, while 77 (68.7%) eyes exhibited signs of exudation at the V-1 visit (P = 0.022). No differences in terms of BCVA and OCT findings were detected between the V-1 and V-2 visits. In multiple regression analysis, the difference in BCVA between V0 and V-1 visits was significantly associated with the interval time within these two visits (P = 0.026). CONCLUSION: The COVID-19 pandemic-related postponement in patient care proved to be significantly associated with worse short-term outcomes in these patients.


Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Betacoronavirus , Neovascularización Coroidal/tratamiento farmacológico , Infecciones por Coronavirus/epidemiología , Neumonía Viral/epidemiología , Neovascularización Retiniana/tratamiento farmacológico , Tiempo de Tratamiento , Degeneración Macular Húmeda/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Bevacizumab/uso terapéutico , Neovascularización Coroidal/diagnóstico por imagen , Neovascularización Coroidal/fisiopatología , Femenino , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Pandemias , Cuarentena , Ranibizumab/uso terapéutico , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Proteínas Recombinantes de Fusión/uso terapéutico , Neovascularización Retiniana/diagnóstico por imagen , Neovascularización Retiniana/fisiopatología , Líquido Subretiniano , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/fisiología , Degeneración Macular Húmeda/diagnóstico por imagen , Degeneración Macular Húmeda/fisiopatología
5.
Indian J Ophthalmol ; 68(10): 2291-2293, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32971697

RESUMEN

Coronavirus disease 2019 (COVID-19) is a form of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that has been declared a pandemic by the World Health Organization (WHO). Ocular manifestations related to COVID-19 are uncommon with conjunctivitis being reported in a few cases. We report a unique case of vasculitic retinal vein occlusion (RVO) secondary to COVID-19 in a 52-year-old patient who presented with the diminution of vision in the left eye 10 days after he tested positive for SARS-CoV-2. All investigations for vasculitis were negative. This case supports the mechanism of thrombo-inflammatory state secondary to the "cytokine-storm" as the pathogenesis for systemic manifestations of COVID-19.


Asunto(s)
Betacoronavirus/patogenicidad , Infecciones por Coronavirus/virología , Infecciones Virales del Ojo/virología , Neumonía Viral/virología , Vasculitis Retiniana/virología , Oclusión de la Vena Retiniana/virología , Administración Oral , Inhibidores de la Angiogénesis/uso terapéutico , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/tratamiento farmacológico , Quimioterapia Combinada , Infecciones Virales del Ojo/diagnóstico , Infecciones Virales del Ojo/tratamiento farmacológico , Angiografía con Fluoresceína , Glucocorticoides/uso terapéutico , Humanos , Inyecciones Intravítreas , Masculino , Metilprednisolona/uso terapéutico , Persona de Mediana Edad , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , Ranibizumab/uso terapéutico , Vasculitis Retiniana/diagnóstico , Vasculitis Retiniana/tratamiento farmacológico , Oclusión de la Vena Retiniana/diagnóstico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Tomografía de Coherencia Óptica , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
6.
Graefes Arch Clin Exp Ophthalmol ; 258(12): 2655-2660, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32960319

RESUMEN

PURPOSE: To quantify the shrinking in outpatient and intravitreal injections' volumes in a tertiary referral retina unit secondary to virus causing coronavirus disease 2019 (COVID-19). METHODS: In this retrospective cross-sectional study, we reviewed the charts of all patients who had a visit at a medical retina referral center during the Italian quarantine (from 9th of March 2020 to 3rd of May 2020). Number and characteristics of these data were compared with data from the same period in 2019 (from 9th of March 2019 to 3rd of May 2019). RESULTS: In the 2019 study period, there were 303 patients attending clinic (150 males, 153 females). In the 2020 study period, patients decreased to 75 (48 males, 27 females; P = 0.022 comparing gender prevalence between the two periods) with an overall reduction of 75.2%. Mean ± SD age was 71.4 ± 14.3 years (range 25-93 years) in the 2019 study period and 66.7 ± 13.1 years (range 32-91 years) in the 2020 study period (P = 0.005). The largest drop in outpatient volume was recorded in AMD patients (- 79.9%). Regarding the intravitreal treatments, there were 1252 injections in the 2019 period and 583 injections in the 2020 period (- 53.6% in injections). The drop in intravitreal treatments was larger in patients with posterior uveitis, retinal vein occlusion, and diabetes (- 85.7%, - 61.9%, and - 59.6%, respectively). CONCLUSION: The volume of outpatient visits and intravitreal injections declined during the COVID-19 quarantine. The short- and long-term impacts are that routine in-person visits and intravitreal injections are expected to increase after the quarantine and, even more, after the pandemic.


Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Betacoronavirus , Infecciones por Coronavirus/epidemiología , Visita a Consultorio Médico/estadística & datos numéricos , Pacientes Ambulatorios/estadística & datos numéricos , Neumonía Viral/epidemiología , Enfermedades de la Retina/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Inyecciones Intravítreas , Italia/epidemiología , Masculino , Persona de Mediana Edad , Pandemias , Cuarentena , Derivación y Consulta/estadística & datos numéricos , Enfermedades de la Retina/diagnóstico , Enfermedades de la Retina/fisiopatología , Estudios Retrospectivos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/fisiología
7.
Cochrane Database Syst Rev ; 8: CD004004, 2020 08 26.
Artículo en Inglés | MEDLINE | ID: mdl-32844399

RESUMEN

BACKGROUND: Radiotherapy has been proposed as a treatment for new vessel growth in people with neovascular age-related macular degeneration (AMD). OBJECTIVES: To examine the effects of radiotherapy on neovascular AMD. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS and three trials registers and checked references of included studies. We last searched the databases on 4 May 2020.  SELECTION CRITERIA: We included all randomised controlled trials in which radiotherapy was compared to another treatment, sham treatment, low dosage irradiation or no treatment in people with choroidal neovascularisation (CNV) secondary to AMD. DATA COLLECTION AND ANALYSIS: We used standard procedures expected by Cochrane. We graded the certainty of the evidence using GRADE. We considered the following outcomes at 12 months: best-corrected visual acuity (BCVA) (loss of 3 or more lines, change in visual acuity), contrast sensitivity, new vessel growth, quality of life and adverse effects at any time point.  MAIN RESULTS: We included 18 studies (n = 2430 people, 2432 eyes) of radiation therapy with dosages ranging from 7.5 to 24 Gy. These studies mainly took place in Europe and North America but two studies were from Japan and one multicentre study included sites in South America. Three of these studies investigated brachytherapy (plaque and epimacular), the rest were studies of external beam radiotherapy (EBM) including one trial of stereotactic radiotherapy. Four studies compared radiotherapy combined with anti-vascular endothelial growth factor (anti-VEGF) with anti-VEGF alone. Eleven studies gave no radiotherapy treatment to the control group; five studies used sham irradiation; and one study used very low-dose irradiation (1 Gy). One study used a mixture of sham irradiation and no treatment. Fifteen studies were judged to be at high risk of bias in one or more domains. Radiotherapy versus no radiotherapy There may be little or no difference in loss of 3 lines of vision at 12 months in eyes treated with radiotherapy compared with no radiotherapy (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.64 to 1.04, 811 eyes, 8 studies, I2 = 66%, low-certainty evidence). Low-certainty evidence suggests a small benefit in change in visual acuity (mean difference (MD) -0.10 logMAR, 95% CI -0.17 to -0.03; eyes = 883; studies = 10) and average contrast sensitivity at 12 months (MD 0.15 log units, 95% CI 0.05 to 0.25; eyes = 267; studies = 2). Growth of new vessels (largely change in CNV size) was variably reported and It was not possible to produce a summary estimate of this outcome. The studies were small with imprecise estimates and there was no consistent pattern to the study results (very low-certainty evidence). Quality of life was only reported in one study of 199 people; there was no clear difference between treatment and control groups (low-certainty evidence). Low-certainty evidence was available on adverse effects from eight of 14 studies. Seven studies reported on radiation retinopathy and/or neuropathy. Five of these studies reported no radiation-associated adverse effects. One study of 88 eyes reported one case of possible radiation retinopathy. One study of 74 eyes graded retinal abnormalities in some detail and found that 72% of participants who had radiation compared with 71% of participants in the control group had retinal abnormalities resembling radiation retinopathy or choroidopathy. Four studies reported cataract surgery or progression: events were generally few with no consistent evidence of any increased occurrence in the radiation group. One study noted transient disturbance of the precorneal tear film but there was no evidence from the other two studies that reported dry eye of any increased risk with radiation therapy. None of the participants received anti-VEGF injections. Radiotherapy combined with anti-VEGF versus anti-VEGF alone People receiving radiotherapy/anti-VEGF were probably more likely to lose 3 or more lines of BCVA at 12 months compared with anti-VEGF alone (RR 2.11, 95% CI 1.40 to 3.17, 1050 eyes, 3 studies, moderate-certainty). Most of the data for this outcome come from two studies of epimacular brachytherapy (114 events) compared with 20 events from the one trial of EBM. Data on change in BCVA were heterogenous (I2 = 82%). Individual study results ranged from a small difference of -0.03 logMAR in favour of radiotherapy/anti-VEGF to a difference of 0.13 logMAR in favour of anti-VEGF alone (low-certainty evidence). The effect differed depending on how the radiotherapy was delivered (test for interaction P = 0.0007). Epimacular brachytherapy was associated with worse visual outcomes (MD 0.10 logMAR, 95% CI 0.05 to 0.15, 820 eyes, 2 studies) compared with EBM (MD -0.03 logMAR, 95% CI -0.09 to 0.03, 252 eyes, 2 studies). None of the included studies reported contrast sensitivity or quality of life. Growth of new vessels (largely change in CNV size) was variably reported in three studies (803 eyes). It was not possible to produce a summary estimate and there was no consistent pattern to the study results (very low-certainty evidence). For adverse outcomes, variable results were reported in the four studies. In three studies reports of adverse events were low and no radiation-associated adverse events were reported. In one study of epimacular brachytherapy there was a higher proportion of ocular adverse events (54%) compared to the anti-VEGF alone (18%). The majority of these adverse events were cataract. Overall 5% of the treatment group had radiation device-related adverse events (17 cases); 10 of these cases were radiation retinopathy. There were differences in average number of injections given between the four studies (1072 eyes). In three of the four studies, the anti-VEGF alone group on average received more injections (moderate-certainty evidence). AUTHORS' CONCLUSIONS: The evidence is uncertain regarding the use of radiotherapy for neovascular AMD. Most studies took place before the routine use of anti-VEGF, and before the development of modern radiotherapy techniques such as stereotactic radiotherapy. Visual outcomes with epimacular brachytherapy are likely to be worse, with an increased risk of adverse events,  probably related to vitrectomy. The role of stereotactic radiotherapy combined with anti-VEGF is currently uncertain. Further research on radiotherapy for neovascular AMD may not be justified until current ongoing studies have reported their results.


Asunto(s)
Degeneración Macular/radioterapia , Sesgo , Braquiterapia/efectos adversos , Braquiterapia/métodos , Terapia Combinada/métodos , Ojo/efectos de la radiación , Humanos , Traumatismos por Radiación/complicaciones , Radioterapia/efectos adversos , Dosificación Radioterapéutica , Ensayos Clínicos Controlados Aleatorios como Asunto , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/efectos de la radiación
8.
Med Sci (Paris) ; 36(8-9): 753-762, 2020.
Artículo en Francés | MEDLINE | ID: mdl-32821052

RESUMEN

Macular edema is an increase in volume of the central area of the retina, responsible for visual acuity. Visual symptoms handicap the lives of millions of patients with macular edema secondary to chronic and sometimes acute retinal disease. Proteins that neutralize the vascular endothelial growth factor (VEGF) pathway or glucocorticoids, at the cost of repeated intraocular injections over years, limit visual symptoms. A better understanding of why and how edema forms and how therapeutic molecules exert an anti-edematous effect will help prevent this disabling and blinding retinal complication from occurring.


Asunto(s)
Edema Macular/etiología , Edema Macular/terapia , Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Glucocorticoides/uso terapéutico , Humanos , Transducción de Señal/efectos de los fármacos , Transducción de Señal/fisiología , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Factor A de Crecimiento Endotelial Vascular/inmunología , Agudeza Visual/efectos de los fármacos , Agudeza Visual/fisiología
9.
Graefes Arch Clin Exp Ophthalmol ; 258(12): 2639-2645, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32712708

RESUMEN

PURPOSE: To assess the treatment position of all patients who have had an anti-VEGF injection in 2020, prior to the UK lockdown on 23 March. To assess methods of service quality evaluation in setting benchmarks for comparison after the situation stabilized. To consider what proportion could be delayed based on national guidelines and varying vision parameters. Finally, to measure how many patients actually attended. METHOD: A retrospective analysis of data collected from our electronic medical record was performed. Age, sex, reason for injection, visual acuity (VA) for both treated and untreated eyes and number of injections were recorded. The proportion of patients and eyes with ≥ 70 letters were calculated as an assessment of quality of service provision. The proportion of patients that could be delayed was estimated based on published guidelines and varying the parameters of difference between treated and untreated eyes. Finally, the number of patients who actually attended was recorded. RESULTS: About 3364 eyes (2229 neovascular age-related macular degeneration (nAMD), 427 diabetic macular oedema (DMO), 599 retinal vein occlusion (RVO) and 109 other) from 2924 patients were analysed. At the last appointment with injection, 64.4% of patients achieved ≥ 70 letters in their better-seeing eye. Mean VA of the treated eye was 61.5 letters, and 36.9% achieved ≥ 70. The mean number of injections was 16, 90% with aflibercept. Of the patients receiving treatment to one eye, 57.6% was receiving treatment to their worse seeing eye. In 18.2% this eye was > 20 letters worse and in 5.07% > 40 letters worse than the untreated eye. Using Royal College of Ophthalmologists (RCOphth) guidelines, (treat nAMD 8 weekly, delay majority of RVO and DMO) 24.8% would be delayed. From 2738 appointments during the first 4 weeks of lockdown (booked prior to lockdown), doctors rescheduled 1025 and patients did not attend 820, leaving 893 who were seen (33%). CONCLUSIONS: Assessing the treatment position of patients prior to COVID-19 lockdown enables objective stratification for prioritization for continued treatment. If RCOphth guidelines were followed 24.8% could be delayed and if treating the worse seeing eye up to 57.6%. Many scheduled patients elected not to attend, with 67% not seen in the first 4 weeks. The impact of non-attendance and delays may be evaluated later.


Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Betacoronavirus , Infecciones por Coronavirus/epidemiología , Accesibilidad a los Servicios de Salud , Edema Macular/tratamiento farmacológico , Neumonía Viral/epidemiología , Oclusión de la Vena Retiniana/tratamiento farmacológico , Degeneración Macular Húmeda/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Neovascularización Coroidal/tratamiento farmacológico , Femenino , Prioridades en Salud , Investigación sobre Servicios de Salud , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Pandemias , Cuarentena/estadística & datos numéricos , Estudios Retrospectivos , Reino Unido/epidemiología , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/fisiología , Adulto Joven
10.
Cochrane Database Syst Rev ; 7: CD009510, 2020 07 07.
Artículo en Inglés | MEDLINE | ID: mdl-32633861

RESUMEN

BACKGROUND: Branch retinal vein occlusion (BRVO) is one of the most commonly occurring retinal vascular abnormalities. The most common cause of visual loss in people with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss. Limitations to this treatment exist, however, and newer modalities may have equal or improved efficacy. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) has recently been used successfully to treat MO resulting from a variety of causes. OBJECTIVES: To investigate the efficacy and gather evidence from randomised controlled trials (RCTs) on the potential harms of anti-vascular endothelial growth factor (VEGF) agents for the treatment of macular oedema (MO) secondary to branch retinal vein occlusion (BRVO). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); MEDLINE Ovid; Embase Ovid; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP. The date of the last search was 12 June 2019. SELECTION CRITERIA: We included randomised controlled trials (RCTs) investigating BRVO. Eligible trials had to have at least six months' follow-up where anti-VEGF treatment was compared with another treatment, no treatment, or placebo. We excluded trials where combination treatments (anti-VEGF plus other treatments) were used; and trials that investigated the dose and duration of treatment without a comparison group (other treatment/no treatment/sham). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data using standard methodological procedures expected by Cochrane. The primary outcome was the proportion of participants with an improvement from baseline in best-corrected visual acuity of greater than or equal to 15 letters (3 lines) on the Early Treatment in Diabetic Retinopathy Study (ETDRS) Chart at six months and 12 months of follow-up. The secondary outcomes were the proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean visual acuity (VA) change at six and 12 months, as well as the change in central retinal thickness (CRT) on optical coherence tomography from baseline at six and 12 months. We also collected data on adverse events and quality of life (QoL). MAIN RESULTS: We found eight RCTs of 1631 participants that met the inclusion criteria after independent and duplicate review of the search results. These studies took place in Europe, North America, Eastern Mediterranean region and East Asia. Included participants were adults aged 18 or over with VA of 20/40 or worse. Studies varied by duration of disease but permitted previously treated eyes as long as there was sufficient treatment-free interval. All anti-VEGF agents (bevacizumab, ranibizumab and aflibercept) and steroids (triamcinolone and dexamethasone) were included. Overall, we judged the studies to be at moderate or unclear risk of bias. Four of the eight studies did not mask participants or outcome assessors, or both. One trial compared anti-VEGF to sham. At six months, eyes receiving anti-VEGF were significantly more likely to have a gain of 15 or more ETDRS letters (risk ratio (RR) 1.72, 95% confidence interval (CI) 1.19 to 2.49; 283 participants; moderate-certainty evidence). Mean VA was better in the anti-VEGF group at six months compared with control (mean difference (MD) 7.50 letters, 95% CI 5.29 to 9.71; 282 participants; moderate-certainty evidence). Anti-VEGF also proved more effective at reducing CRT at six months (MD -57.50 microns, 95% CI -108.63 to -6.37; 281 participants; lower CRT is better; moderate-certainty evidence). There was only very low-certainty evidence on adverse effects. There were no reports of endophthalmitis. Mean change in QoL (measured using the National Eye Institute Visual Functioning Questionnaire VFQ-25) was better in people treated with anti-VEGF compared with people treated with sham (MD 7.6 higher score, 95% CI 4.3 to 10.9; 281 participants; moderate-certainty evidence). Three RCTs compared anti-VEGF with macular laser (total participants = 473). The proportion of eyes gaining 15 or more letters was greater in the anti-VEGF group at six months (RR 2.09, 95% CI 1.44 to 3.05; 2 studies, 201 participants; moderate-certainty evidence). Mean VA in the anti-VEGF groups was better than the laser groups at six months (MD 9.63 letters, 95% CI 7.23 to 12.03; 3 studies, 473 participants; moderate-certainty evidence). There was a greater reduction in CRT in the anti-VEGF group compared with the laser group at six months (MD -147.47 microns, 95% CI -200.19 to -94.75; 2 studies, 201 participants; moderate-certainty evidence). There was only very low-certainty evidence on adverse events. There were no reports of endophthalmitis. QoL outcomes were not reported. Four studies compared anti-VEGF with intravitreal steroid (875 participants). The proportion of eyes gaining 15 or more ETDRS letters was greater in the anti-VEGF group at six months (RR 1.67, 95% CI 1.33 to 2.10; 2 studies, 330 participants; high-certainty evidence) and 12 months (RR 1.76, 95% CI 1.36 to 2.28; 1 study, 307 participants; high-certainty evidence). Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence). Mean CRT also showed a greater reduction in the anti-VEGF arm at 12 months compared with intravitreal steroid (MD -26.92 microns, 95% CI -65.88 to 12.04; 2 studies, 343 participants; moderate-certainty evidence). People receiving anti-VEGF showed a greater improvement in QoL at 12 months compared to those receiving steroid (MD 3.10, 95% CI 0.22 to 5.98; 1 study, 307 participants; moderate-certainty evidence). Moderate-certainty evidence suggested increased risk of cataract and raised IOP with steroids. There was only very low-certainty evidence on APTC events. No cases of endophthalmitis were observed. AUTHORS' CONCLUSIONS: The available RCT evidence suggests that treatment of MO secondary to BRVO with anti-VEGF improves visual and anatomical outcomes at six and 12 months.


Asunto(s)
Inhibidores de la Angiogénesis/administración & dosificación , Anticuerpos Monoclonales Humanizados/administración & dosificación , Edema Macular/tratamiento farmacológico , Oclusión de la Vena Retiniana/complicaciones , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Inhibidores de la Angiogénesis/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Bevacizumab/administración & dosificación , Humanos , Inyecciones Intravítreas , Coagulación con Láser , Terapia por Láser , Edema Macular/etiología , Edema Macular/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Ranibizumab/administración & dosificación , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Terapia Recuperativa/métodos , Esteroides/administración & dosificación , Agudeza Visual/efectos de los fármacos
11.
J Fr Ophtalmol ; 43(8): 761-769, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32622633

RESUMEN

INTRODUCTION: To describe the one-year functional outcomes of treatment-naïve neovascular age-related macular degeneration (nAMD) treated with anti-VEGF agents at the Dijon University Hospital Ophthalmology Department. METHODS: Real-life interventional study including all treatment-naïve nAMD patients from January 2016 to December 2018 in the Ophthalmology Department of Dijon University Hospital. Data were retrospectively collected from the Fight Retinal Blindness! (FRB!) registry. At baseline, medical history, visual acuity (VA), type of lesion and activity on angiography and optical coherence tomography (OCT), and treatment were recorded. On follow-up, VA, lesion activity and treatment were recorded. RESULTS: Three-hundred twenty eyes of 259 patients were included, of which 65.6% were female and with a mean age of 80.1±11.1 years. Mean VA (standard deviation, SD) at baseline was 53.2 ETDRS letters (25.3). All patients received anti-VEGF injections, of which 164 eyes (51.2%), 152 eyes (47.5%) and 4 eyes (1.2%) were treated with aflibercept, ranibizumab and bevacizumab, respectively. A total of 198 eyes of 169 patients completed the 12-month follow-up, with a median (first quartile, third quartile) of 12 visits (10, 13). At one year (n=198), the overall mean VA gain [95% CI] was +3.3 ETDRS letters [0.7, 5.9] and 173 (87.4%) of the treated eyes did not lose 15 or more letters. We found no statistically significant difference in mean VA gain between aflibercept and ranibizumab. CONCLUSION: This real-world study confirmed the efficacy of anti-VEGF agents in nAMD and the feasibility of analyzing data in an international registry.


Asunto(s)
Inhibidores de la Angiogénesis/administración & dosificación , Degeneración Macular/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/efectos adversos , Bevacizumab/administración & dosificación , Bevacizumab/efectos adversos , Ceguera/tratamiento farmacológico , Ceguera/epidemiología , Femenino , Francia/epidemiología , Humanos , Inyecciones Intravítreas , Degeneración Macular/epidemiología , Masculino , Neovascularización Patológica/tratamiento farmacológico , Neovascularización Patológica/epidemiología , Ranibizumab/administración & dosificación , Ranibizumab/efectos adversos , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Proteínas Recombinantes de Fusión/efectos adversos , Sistema de Registros , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Factor A de Crecimiento Endotelial Vascular/inmunología
13.
J Fr Ophtalmol ; 43(7): 618-625, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32473741

RESUMEN

PURPOSE: To evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections (IVT) in diabetic macular edema (DME) in real-life practice using the Save Sight Registries (SSR). MATERIAL AND METHODS: We conducted an observational, single-centre, retrospective study in the department of ophthalmology of the Dijon University Hospital. We included treatment-naive patients who presented with DME between January 2016 and December 2017. Demographic and clinical data, follow-up visits, and treatments administered were entered into the SSR, an international online ophthalmic registry. Primary endpoints were the change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to 12 and 24 months. RESULTS: Fifty-eight eyes of 43 patients with a mean [standard deviation (SD)] age of 67.1 [9.5] years were included. Forty-one eyes completed 12 months of follow-up, and 17 eyes completed 24 months of follow up. Median [SD] baseline BCVA was 56.1 [22.9] ETDRS letters and the median [95% confidence interval (95% CI)] baseline CST was 447.9 [161.0] micrometers (µm). Median [95% CI] improvement in BCVA from baseline to months 12 and 24 were respectively, +5.6 [+0.5; +10.7] ETDRS letters and +7.7 [-2.8; +18.2] ETDRS letters. The median [95% CI] decrease in CST from baseline to months 12 and 24 were respectively, -110.9 [-154.5; -67.3] µm and -125.5 [-198.0; -53.0] µm. CONCLUSION: Our clinical practice can be evaluated easily with the SSR system. In real life, anti-VEGF IVT are an effective treatment for DME, which result in improved BCVA and decreased CST.


Asunto(s)
Bevacizumab/administración & dosificación , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Centros Médicos Académicos , Anciano , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Bevacizumab/efectos adversos , Retinopatía Diabética/epidemiología , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Inyecciones Intravítreas , Edema Macular/epidemiología , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/estadística & datos numéricos , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Factor A de Crecimiento Endotelial Vascular/inmunología
14.
Middle East Afr J Ophthalmol ; 27(1): 4-9, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32549717

RESUMEN

Peripheral exudative hemorrhagic chorioretinopathy (PEHCR) is a rare retinal vasculopathy that might cause subretinal and/or vitreous hemorrhages. Although the primary etiology is still unknown, choroidal neovascularization is mainly involved in the pathogenesis. The main risk factors are age and systemic hypertension. Ancillary testing such as fluorescein angiography, indocyanine green angiography and ultrasonography can be of great value for diagnosing this entity and distinguishing PEHCR from other lesions as choroidal melanoma and retinal vasoproliferative tumor. Various treatments have been reported including photocoagulation, cryotherapy, intravitreal injection of anti-vascular endothelial growth factor (Anti-VEGF) and surgical intervention as pars plana vitrectomy. This review handles an up-to-date perspective regarding PEHCR.


Asunto(s)
Hemorragia Retiniana/etiología , Hemorragia Vítrea/etiología , Inhibidores de la Angiogénesis/uso terapéutico , Colorantes/administración & dosificación , Crioterapia , Angiografía con Fluoresceína , Humanos , Verde de Indocianina/administración & dosificación , Inyecciones Intravítreas , Coagulación con Láser , Hemorragia Retiniana/diagnóstico , Hemorragia Retiniana/terapia , Factores de Riesgo , Tomografía de Coherencia Óptica , Ultrasonografía , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Vitrectomía , Hemorragia Vítrea/diagnóstico , Hemorragia Vítrea/terapia
15.
J Chin Med Assoc ; 83(9): 817-821, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32568969

RESUMEN

As the coronavirus disease 2019 (COVID-19, also called severe acute respiratory syndrome coronavirus-2) outbreak accelerates, vigorous and diverse efforts were made in developing treatment strategies. In addition to direct acting agents, increasing evidence showed some potential adjuvant therapies with promising efficacy against COVID-19. These therapies include immunomodulators (i.e. intravenous immunoglobulin, thymosin α-1, interleukin [IL]-6, tocilizumab, cyclosporine, thalidomide, fingolimod), Chinese medicines (i.e. glycyrrhizin, baicalin, Xuebijing), anti-vascular endothelial growth factors (bevacizumab), estrogen modulating drugs, statins, and nutritional supplements (i.e. vitamins A, B, C, D, E and zinc). This article reviewed the pharmacological development of potential adjuvants for COVID-19 treatment.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Suplementos Dietéticos , Humanos , Factores Inmunológicos/uso terapéutico , Medicina China Tradicional , Apoyo Nutricional , Pandemias , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
16.
Int J Clin Oncol ; 25(10): 1757-1762, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32591963

RESUMEN

OBJECTIVES: Contrast nephropathy risk has been increasing in cancer patients. Nephrotoxic side effects of anti-vascular endothelial growth factor/receptor (anti-VEGF/R) drugs used in oncologic treatment are also prominent. The purpose of this study was to identify the possible association among anti-VEGF/R drugs use and development of the contrast-induced nephropathy (CIN) in patients with cancers. METHODS: A total of 92 patients were included in this prospective cross-sectional study. Patients whose glomerular filtration rate (GFR) of < 50 ml/min, hemoglobin of < 10 g/dl, and eastern cooperative oncology group (ECOG) score of ≥ 2 and had received nephrotoxic drugs were not included in the study. Blood samples were collected baseline at pre computed tomography (CT) and day 2, day 3 and day 7 later CT imaging. CIN was defined as either an increased serum creatinine value of 0.5 mg/dl or increased 25% to baseline. CIN frequency between groups receivingand not receiving anti-VEGF/R was compared using the chi-squared test. CIN frequency between bevacizumab and other anti-VEGF/R was also analyzed. RESULTS: There were 39 patients in the anti-VEGF/R (+) group and 53 patients in the anti-VEGF/R (-) group. Eleven patients (28%) in the anti-VEGF/R (+) group and 3 patients (5.6%) in the anti-VEGF/R (-) group had CIN (p = 0.006). In the anti-VEGF/R (+) group, 23 patients received bevacizumab (combined with FOLFOX/FOLFIRI), while 16 patients received other anti-VEGF/R (sunitinib, axitinib, regorafenib, aflibercept) effective treatments. CIN ratio in patients who received bevacizumab or other anti-VEGFR therapy was similar (p = 0 = 50). Of the patients, one patient had acute kidney injury leading to death. CONCLUSION: CIN was significantly more frequent in cancer patients who receiving anti-VEGF/R drugs than those not receiving anti-VEGF/R drugs.


Asunto(s)
Medios de Contraste/efectos adversos , Enfermedades Renales/inducido químicamente , Terapia Molecular Dirigida/efectos adversos , Tomografía Computarizada por Rayos X/efectos adversos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Lesión Renal Aguda/inducido químicamente , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/efectos adversos , Creatinina/sangre , Estudios Transversales , Femenino , Tasa de Filtración Glomerular/efectos de los fármacos , Humanos , Enfermedades Renales/metabolismo , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Estudios Prospectivos , Receptores de Factores de Crecimiento Endotelial Vascular , Proteínas Recombinantes de Fusión/efectos adversos , Factores de Riesgo , Tomografía Computarizada por Rayos X/métodos
17.
Br J Cancer ; 123(5): 694-697, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32572174
18.
Digit J Ophthalmol ; 26(1): 1-7, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32547330

RESUMEN

Type 1 extrafoveal choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration was diagnosed in a 68-year-old woman using optical coherence tomography angiography (OCT-A) alone. The entire network of vessels was clearly visible on a 12 × 12 mm OCT-A scan segmented below the retinal pigment epithelium. The patient was initially treated with intravitreal ranibizumab followed by photodynamic therapy (PDT) guided by OCT-A. Complete resolution of subretinal fluid with shrinkage of the neovascular complex was noted 1 month after PDT.


Asunto(s)
Neovascularización Coroidal/tratamiento farmacológico , Angiografía con Fluoresceína , Fotoquimioterapia , Fármacos Fotosensibilizantes/uso terapéutico , Tomografía de Coherencia Óptica , Degeneración Macular Húmeda/tratamiento farmacológico , Anciano , Inhibidores de la Angiogénesis/uso terapéutico , Neovascularización Coroidal/diagnóstico por imagen , Quimioterapia Combinada , Femenino , Fóvea Central , Humanos , Inyecciones Intravítreas , Ranibizumab/uso terapéutico , Líquido Subretiniano , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Degeneración Macular Húmeda/diagnóstico por imagen
19.
Am J Ophthalmol ; 218: 225-241, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32565050

RESUMEN

PURPOSE: To perform 11- and 2-year health care sector (ophthalmic) and societal cost perspective reference case, cost-utility analyses comparing bevacizumab, ranibizumab, and aflibercept monotherapies for neovascular age-related macular degeneration (NVAMD). DESIGN: Cost-utility analysis. METHODS: The authors performed 11-year and 2-year ophthalmic and societal cost perspective, cost-utility analyses comparing bevacizumab, ranibizumab, and aflibercept monotherapies for neovascular age-related macular degeneration (NVAMD). We employed patient utilities, bilateral outcomes, 2018 U.S. dollars, vision-related mortality, a Medicare fee schedule, and CATT (Comparison of Age-Related Macular Degeneration Treatments) study and VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) trial. Cochrane data were also used. SETTING: Center for Value-Based Medicine. Patient/study population: patients with NVAMD. INTERVENTION: Cost-utility analyses using published data. Data-modeled 10-year vision outcomes were modeled forward to year 11. MAIN OUTCOME MEASUREMENT: These included cost-utility ratios (CURs), costs, and quality-adjusted life-years (QALYs) gained. $100,00/QALY was considered the US cost-effectiveness upper limit. RESULTS: Bevacizumab and ranibizumab each conferred an 11-year, 1.339 QALY gain versus observation. Aflibercept conferred a 1.380 QALY gain. Aflibercept conferred greater QALY gain for less cost than ranibizumab but was not cost-effective compared to bevacizumab ($1,151,451/QALY incremental CUR). The average ophthalmic cost perspective CUR for bevacizumab was $11,033/QALY, $79,600/QALY for ranibizumab, and $44,801/QALY for aflibercept. Eleven-year therapies saved a 1.0 year-of-life loss without treatment from the 11.0-year life expectancy. Early treatment was 138%-149% more cost-effective than late treatment. Two-year therapy prevented a 1-month-of-life loss, and revealed bevacizumab, ranibizumab, and aflibercept conferred 0.141, 0.141, and 0.164 QALY gains, respectively, with corresponding average CURs of $40,371/QALY, $335,726/QALY, and $168,006/QALY, respectively. CONCLUSIONS: From an ophthalmic (medical) cost perspective, bevacizumab, ranibizumab, and aflibercept NVAMD monotherapies were all cost-effective over 11 years, with bevacizumab 6.21× more cost-effective than ranibizumab and 3.06× more cost-effective than aflibercept. Two-year modeling revealed bevacizumab was cost-effective, whereas ranibizumab and aflibercept were not. Early treatment was critical for obtaining optimal vision and cost-effectiveness, as is long-term follow-up and adherence to treatment.


Asunto(s)
Inhibidores de la Angiogénesis/economía , Neovascularización Coroidal/economía , Análisis Costo-Beneficio , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Factor A de Crecimiento Endotelial Vascular/economía , Degeneración Macular Húmeda/economía , Anciano , Inhibidores de la Angiogénesis/uso terapéutico , Bevacizumab/economía , Bevacizumab/uso terapéutico , Neovascularización Coroidal/tratamiento farmacológico , Costos de los Medicamentos , Femenino , Costos de la Atención en Salud , Humanos , Inyecciones Intravítreas , Masculino , Medicare , Años de Vida Ajustados por Calidad de Vida , Ranibizumab/economía , Ranibizumab/uso terapéutico , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Proteínas Recombinantes de Fusión/economía , Proteínas Recombinantes de Fusión/uso terapéutico , Estados Unidos , Agudeza Visual , Degeneración Macular Húmeda/tratamiento farmacológico
20.
Drugs Today (Barc) ; 56(5): 311-320, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32406878

RESUMEN

Wet age-related macular degeneration (w-AMD) represents the main cause of vision loss in the elderly in the western countries. The important role displayed by vascular endothelial growth factor (VEGF) in the pathogenesis of this disease has been largely demonstrated. For this reason, anti-VEGF drugs have been developed and currently are considered as the first-line treatment options in the management of w-AMD. Among the novel anti-VEGF agents studied, conbercept is a fusion protein composed of the combination between VEGF receptor domains with the Fc fragment of human immunoglobulin. It was already approved in China in 2014 for treating w-AMD. In this regard, the phase III PHOENIX trial has reported a good clinical efficacy and safety profile of conbercept for w-AMD, also by adopting a quarterly regimen. In this review, we will discuss its pharmacokinetics, pharmacodynamics, clinical efficacy, without neglecting also its safety and tolerability profile.


Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Degeneración Macular/tratamiento farmacológico , Proteínas Recombinantes de Fusión/uso terapéutico , Anciano , Ensayos Clínicos Fase III como Asunto , Humanos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
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