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1.
Vestn Oftalmol ; 137(1): 83-93, 2021.
Artigo em Russo | MEDLINE | ID: mdl-33610155

RESUMO

The problem associated with the prevalence of retinal diseases, and age-related macular degeneration (AMD) in particular, is undoubtedly relevant. This aspect is based on steadily growing statistics on morbidity, a high number of randomized controlled trials (RCT) and published real world data (RWD). The analysis of RCT results being published by researchers on 15.05.19 showed 2915 studies were registered on the subject of retinal diseases; that exceeds the number of studies on glaucoma by approximately 1.38 times (2118 studies) and conjunctival lesions by 2.37 times (1230 studies). AMD is one of the leading causes of irreversible vision loss and blindness; its neovascular form leads to blindness in 80-90% of all cases. Even though the topic of nAMD therapy is widely highlighted in modern ophthalmology, today there are many aspects that require targeted solutions. The main controversial issues that determine the complexity of therapy and patient management include discrepancies in determination of reference points (disease activity criteria) for implementation of anti-VEGF dosing regimens, patients' compliance, prioritization issues in treatment, its continuity with potential for the increase of intervals between injections and monitoring visits.


Assuntos
Degeneração Macular , Degeneração Macular Exsudativa , Inibidores da Angiogênese/uso terapêutico , Humanos , Injeções Intravítreas , Degeneração Macular/diagnóstico , Degeneração Macular/tratamento farmacológico , Ranibizumab/uso terapêutico , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular , Acuidade Visual , Degeneração Macular Exsudativa/diagnóstico , Degeneração Macular Exsudativa/tratamento farmacológico
2.
BMJ Case Rep ; 14(2)2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33526522

RESUMO

A 44-year-old woman presented with decreased vision in both eyes. The retina in both eyes had drusen distributed along vascular arcades, central macula and in peripapillary region. Macula had pigmented scarring and exudation. Fundus autofluorescence showed drusen. Optical coherence tomography showed drusen, subretinal and intraretinal fluid. Fundus fluorescein and indocyanine green angiography showed drusen, retinal pigment epithelial atrophy and vascular network. Younger age at presentation, bilateral symmetry, typical distribution of drusen along the arcades in a radiating pattern, peripapillary involvement, scarring and atrophy at macula were suggestive of doyne honeycomb retinal dystrophy. The reduced vision was due to macular atrophy and an active choroidal neovascular membrane. The patient was treated with antivascular endothelial growth factor injections for choroidal neovascular membrane. Our case highlights the importance of pattern recognition and multimodal imaging for diagnosing the type of macular dystrophy as doyne honeycomb retinal dystrophy, while simultaneously managing choroidal neovascular membrane.


Assuntos
Neovascularização de Coroide/diagnóstico por imagem , Angiofluoresceinografia , Tomografia de Coerência Óptica , Adulto , Inibidores da Angiogênese/uso terapêutico , Angiografia , Neovascularização de Coroide/complicações , Neovascularização de Coroide/tratamento farmacológico , Corantes , Feminino , Fundo de Olho , Humanos , Verde de Indocianina , Injeções Intravítreas , Imagem Multimodal , Drusas do Disco Óptico/complicações , Drusas do Disco Óptico/congênito , Drusas do Disco Óptico/diagnóstico por imagem , Ranibizumab/uso terapêutico
3.
Paediatr Drugs ; 23(1): 111-117, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33447937

RESUMO

Ranibizumab (Lucentis®) is a monoclonal antibody fragment targeted against VEGF-A that is the first approved anti-VEGF agent for the treatment of retinopathy of prematurity (ROP). In the pivotal, randomized, phase III RAINBOW trial in infants with ROP, the majority of intravitreal ranibizumab recipients experienced treatment success at 24 weeks, with a numerically greater treatment success rate in the ranibizumab 0.2 mg (80% of patients) than laser therapy (66%) group without reaching statistical significance for superiority. Long-term effects on vision following ranibizumab treatment are not yet known, but interim analyses from the RAINBOW extension study do not show evidence of degraded vision. Adverse reactions to ranibizumab in pediatric patients were consistent with the known safety profile in adults, with most adverse reactions attributed to the intravitreal injection procedure. Furthermore, systemic VEGF suppression was not observed in clinical trials, which is congruent with the rapid systemic clearance of ranibizumab. Overall, ranibizumab is an effective and generally well tolerated treatment for ROP and is not associated with systemic VEGF suppression. Although results for its long-term effects on vision are not yet available, ranibizumab is a promising alternative option to laser therapy for treating ROP.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Ranibizumab/uso terapêutico , Retinopatia da Prematuridade/tratamento farmacológico , Inibidores da Angiogênese/farmacologia , Humanos , Recém-Nascido , Ranibizumab/efeitos adversos , Ranibizumab/farmacologia , Resultado do Tratamento
4.
BMJ Case Rep ; 14(1)2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-33472799

RESUMO

We report the case of a 19-year-old patient with symptomatic unilateral serous maculopathy associated with an optic nerve coloboma. Fluorescein angiography detected a focal late leak at the temporal edge of the coloboma which was later found to correspond with an area of choroidal neovascularisation on optical coherence tomography angiography. A course of intravitreal ranibizumab achieved good clinical and structural response. This report contributes to the evidence that maculopathies associated with cavitary optic nerve anomalies may in some instances result from choroidal neovascularisation. It also highlights the importance of angiography to identify potential choroidal neovascular membranes, particularly in the absence of haemorrhages and neovascular membranes on fundus examination and conventional optical coherence tomography.


Assuntos
Coriorretinopatia Serosa Central/diagnóstico por imagem , Neovascularização de Coroide/diagnóstico por imagem , Coloboma/diagnóstico por imagem , Nervo Óptico/anormalidades , Inibidores da Angiogênese , Coriorretinopatia Serosa Central/complicações , Coriorretinopatia Serosa Central/tratamento farmacológico , Coriorretinopatia Serosa Central/patologia , Neovascularização de Coroide/complicações , Neovascularização de Coroide/tratamento farmacológico , Neovascularização de Coroide/patologia , Coloboma/complicações , Coloboma/patologia , Feminino , Angiofluoresceinografia , Humanos , Injeções Intravítreas , Nervo Óptico/diagnóstico por imagem , Nervo Óptico/patologia , Ranibizumab/uso terapêutico , Tomografia de Coerência Óptica , Resultado do Tratamento , Adulto Jovem
6.
Vestn Oftalmol ; 136(6. Vyp. 2): 227-234, 2020.
Artigo em Russo | MEDLINE | ID: mdl-33371654

RESUMO

Age-related macular degeneration is an advanced chronic disease and the main cause of vision loss in geriatric patients. Optical coherence tomography (OCT) is a modern method of retinal imaging allowing to detect different types of fluid: intraretinal fluid (IRF), subretinal fluid (SRF) and fluid under pigment epithelial detachment (PED). Finding relevant imaging biomarkers is necessary for identification of basic activity criteria of the disease, choosing treatment algorithms, determining treatment duration and termination criteria, and predicting the outcomes. Presence of IRF is associated with poor functional outcomes. Its presence is an indication for early beginning of treatment aimed at full resorption of the fluid with further possible careful extension of anti-VEGF therapy intervals with a regular follow-up. Degenerative intraretinal cysts developing in the background of subretinal fibrosis in absence of choroidal neovascularization (CNV) should be a sign for discontinuation of anti-VEGF therapy due to the lack of targets. Presence of SRF is associated with favorable outcomes and good treatment prognosis and is not a barrier to the extension of treatment intervals even up to the maximum of 16 weeks as described in existing randomized controlled trials, on the condition of no other CNV activity. PED with active CNV is one of the biomarkers that reveal the need for long-term aggressive therapy. In case of its size gain, it is necessary to restart the anti-VEGF treatment to prevent visual loss in the long-term. Combination of different fluid types is a sign of lasting disease history with a poor outcome prognosis. In this case, anti-VEGF treatment should be started as soon as possible with long-term fixed regimen or Treat-and-extend (T&E) with minimal suitable interval for the patient and precise monitoring of the condition of retina until complete suppression of activity. Developing a personalized approach in each case plays an important role in preserving visual functions.


Assuntos
Neovascularização de Coroide , Degeneração Macular , Idoso , Inibidores da Angiogênese/uso terapêutico , Biomarcadores , Neovascularização de Coroide/diagnóstico , Neovascularização de Coroide/tratamento farmacológico , Neovascularização de Coroide/etiologia , Humanos , Injeções Intravítreas , Degeneração Macular/tratamento farmacológico , Prognóstico , Ranibizumab/uso terapêutico , Retina , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular , Acuidade Visual
7.
PLoS One ; 15(12): e0244183, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33378369

RESUMO

PURPOSE: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study. PATIENTS AND METHODS: LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). RESULTS: At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and ≥5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received ≤6 and >6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively. CONCLUSIONS: Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving ≥6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Efeitos Adversos de Longa Duração/epidemiologia , Degeneração Macular/tratamento farmacológico , Ranibizumab/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Esquema de Medicação , Feminino , Humanos , Masculino , Ranibizumab/administração & dosagem , Ranibizumab/efeitos adversos , Acuidade Visual
8.
Graefes Arch Clin Exp Ophthalmol ; 258(12): 2621-2628, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33009973

RESUMO

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.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Betacoronavirus , Neovascularização de Coroide/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Neovascularização Retiniana/tratamento farmacológico , Tempo para o Tratamento , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Bevacizumab/uso terapêutico , Neovascularização de Coroide/diagnóstico por imagem , Neovascularização de Coroide/fisiopatologia , Feminino , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Pandemias , Quarentena , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Neovascularização Retiniana/diagnóstico por imagem , Neovascularização Retiniana/fisiopatologia , Líquido Sub-Retiniano , Tomografia de Coerência Óptica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade Visual/fisiologia , Degeneração Macular Exsudativa/diagnóstico por imagem , Degeneração Macular Exsudativa/fisiopatologia
9.
Cesk Slov Oftalmol ; 76(4): 1-3, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33086850

RESUMO

The issue of macular retinal degeneration is one of the key areas of ophthalmology. Recent advances in the targeted delivery of vascular endothelial growth factor (VEGF) suppressants have significantly impacted the patient's prognosis in the form of a significant deceleration in disease progression. Some of the drugs have gradually found their use in other indications (central retinal vein occlusion or diabetic macular edema). The following text gives a brief look at the physiology of VEGF, but not only in the eye, but throughout the human body, particularly in the context of adverse effects resulting from systemic inhibition of its effects.


Assuntos
Retinopatia Diabética , Degeneração Macular , Edema Macular , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Humanos , Injeções Intravítreas , Degeneração Macular/tratamento farmacológico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Fator A de Crescimento do Endotélio Vascular , Acuidade Visual
10.
Indian J Ophthalmol ; 68(10): 2291-2293, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32971697

RESUMO

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.


Assuntos
Betacoronavirus/patogenicidade , Infecções por Coronavirus/virologia , Infecções Oculares Virais/virologia , Pneumonia Viral/virologia , Vasculite Retiniana/virologia , Oclusão da Veia Retiniana/virologia , Administração Oral , Inibidores da Angiogênese/uso terapêutico , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Quimioterapia Combinada , Infecções Oculares Virais/diagnóstico , Infecções Oculares Virais/tratamento farmacológico , Angiofluoresceinografia , Glucocorticoides/uso terapêutico , Humanos , Injeções Intravítreas , Masculino , Metilprednisolona/uso terapêutico , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/tratamento farmacológico , Ranibizumab/uso terapêutico , Vasculite Retiniana/diagnóstico , Vasculite Retiniana/tratamento farmacológico , Oclusão da Veia Retiniana/diagnóstico , Oclusão da Veia Retiniana/tratamento farmacológico , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
11.
Brasília; CONITEC; ago. 2020.
Não convencional em Português | BRISA/RedTESA | ID: biblio-1145409

RESUMO

INTRODUÇÃO: O EMD é a principal causa de perda visual observada na retinopatia diabética (RD), a qual é uma das principais complicações relacionadas à diabetes mellitus (DM). Caracteriza-se pelo espessamento do tecido da mácula, como resultado do extravasamento de líquido dos capilares sanguíneos ou a presença de exsudatos duros no centro da mácula. As principais terapias para o tratamento do EMD disponíveis no SUS são terapias a laser (fotocoagulação e pan-fotocoagulação), cirurgia vitrectomia e, conforme a recente incorporação, o antiangiogênico aflibercepte. PERGUNTA: O uso de ranibizumabe é eficaz e seguro como opção de anti-VEGF para o tratamento do edema macular diabético quando comparado aos tratamentos atualmente disponíveis no SUS (fotocoagulação a laser e aflibercepte)? EVIDÊNCIAS CIENTÍFICAS: Foram incluídos 12 estudos pelo demandante, sendo 3 revisões sistemáticas e 9 ensaios clínicos que avaliaram ranibizumabe. Foram também incluídas 2 metanálises que o demandante havia excluído de sua análise original. Todos os estudos primários compararam o ranibizumabe com o tratamento com o laser e apresentaram resultados significativos de superioridade de eficácia do ranibizumabe na melhora da acuidade visual em pacientes com EMD. As revisões sistemáticas que avaliaram o ranibizumabe com outros anti-VEGF mostraram que estes têm eficácia semelhantes, com alguns estudos sugerindo superioridade do aflibercepte como tratamento. Segundo resultados atualizados da metanálise de Virgilli e colaboradores, aflibercepte e ranibizumabe foram mais efetivos do que laser, melhorando a visão em 2 ou mais linhas depois de um ano de tratamento (alta qualidade). O risco relativo (RR) versus laser foi de 3,66 (IC95% 2,79 a 4,79) para aflibercepte e RR 2,76 (IC95% CI 2,12 a 3,59) para ranibizumabe. Pessoas com EMD em tratamento com ranibizumabe foram menos propensas a ganhar 3 ou mais linhas de acuidade visual em um ano comparado com aflibercepte - RR 0,75 (IC95% 0,60 a 0,94). Aflibercepte e ranibizumabe não diferiram com relação a eventos adversos graves sistêmicos. Outra metanálise em rede de Zhang e colaboradores mostrou que ranibizumabe teve melhores resultados que o aflibercepte na melhora do BCVA em 6 meses com odds ratio (OR) 7,01 (IC95% 2,56 a 11,39), mas o aflibercepte apresentou melhor eficácia aos 12 meses de tratamento com OR 8,19 (IC95% 5,07 a 11,96). Esses resultados demonstram que tanto o ranibizumabe quando o aflibercepte tem eficácia semelhante para o EMD. AVALIAÇÃO ECONÔMICA: A avaliação apresentada pelo demandante foi uma análise de custominimização utilizando como comparador o aflibercepte. Ranibizumabe é uma alternativa poupadora de recursos quando comparada ao aflibercepte para o tratamento de pacientes adultos com edema macular diabético (EMD). O custo total estimado com ranibizumabe para três anos de tratamento foi de R$ 18.171,48 e para o aflibercepte de R$ 21.629,11 proporcionando uma economia de aproximadamente 16% com o tratamento com ranibizumabe. A análise apresentada avaliou os custos de tratamento por paciente relacionados a aquisição, administração e acompanhamento e monitorização do tratamento. Porém não considerou gastos relacionados à segurança. Custos com complicações e eventos adversos podem impactar no resultado econômico do tratamento. Como não foram considerados esses custos, faltou avaliar esse parâmetro na análise de sensibilidade disponibilizada. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: A análise de impacto orçamentária (AIO) apresentada incluiu a população estimada com RD com presença de EMD aplicando taxas de prevalência de 11,7% de acordo com estudo realizado no Brasil. O cenário proposto com ranibizumabe projetado para tratamento anual chega a R$ 79.266.917,64 no ano 1 e estima-se R$ 181.283.719,49 no ano 5 em relação ao aflibercepte que teve o valor estimado em R$ 69.312.302,72 para o primeiro ano de incorporação e de R$ 154.658.419,96 para o quinto ano. A AIO demonstrou que a incorporação de ranibizumabe como uma alternativa de tratamento para EMD além do aflibercepte pode promover uma economia de recursos de até R$ 104,1 milhões ao longo de cinco anos considerando uma difusão de mercado de 50%. Em todos os cenários avaliados pela análise de sensibilidade observou-se a geração de economia devido a incorporação de ranibizumabe para EMD no SUS. O modelo possui algumas limitações na análise, como incerteza no tamanho da cota de mercado do ranibizumabe (considerada em 50%), incerteza de que ocorrerá indicação terapêutica apenas para pacientes com espessamento de retina maior que 400 micrometros , incerteza da origem dos valores da taxa de difusão apresentadas o que pode comprometer os resultados. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: As buscas encontraram dois medicamentos novos no horizonte para tratamento do EMD, Brolucizumabe (inibidor de VEGF-A) e Faricizumabe (inibidor VEGF-A e inibidor de ligante de angiopoietina-2) em estudo clínico de fase 3 em andamento. Ainda foram encontrados biossimilares do aflibercepte e ranibizumabe. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Pelo exposto, a Conitec, em sua 86ª reunião ordinária, nos dias 04 e 05 de março de 2020, recomendou-se que o tema fosse levado em consulta pública com recomendação preliminar favorável a incorporação no SUS do Ranibizumabe para o tratamento de pacientes adultos com edema macular diabético (EMD). CONSULTA PÚBLICA: O relatório de recomendação inicial da Conitec foi disponibilizado para contribuições por meio da consulta pública nº 16/2020 entre os dias 30/03/2020 e 20/04/2020. Foram recebidas 978 contribuições, sendo 156 contribuições de cunho técnico-científico e 822 contribuições de experiência pessoal ou opinião. Destas 95,5% e 92,3% concordavam com a recomendação preliminar da Conitec, respectivamente. RECOMENDAÇÃO FINAL DA CONITEC: Os membros da Conitec presentes na 89ª reunião ordinária, no dia 05/08/2020, deliberaram, por unanimidade, recomendar a incorporação do ranibizumabe para o tratamento do edema macular diabético, conforme protocolo do Ministério da Saúde e assistência oftalmológica no SUS. DECISÃO: Incorporar o ranibizumabe para tratamento de Edema Macular Diabético (EMD), no âmbito do Sistema Único de Saúde - SUS, conforme protocolo do Ministério da Saúde e a assistência oftalmológica no SUS, conforme Portaria n° 39, publicada no Diário Oficial da União n° 181, seção 1, página 235, em 21 de setembro de 2020.


Assuntos
Humanos , Edema Macular/tratamento farmacológico , Retinopatia Diabética/fisiopatologia , Ranibizumab/uso terapêutico , Avaliação da Tecnologia Biomédica , Sistema Único de Saúde , Brasil , Análise Custo-Benefício/economia
12.
PLoS One ; 15(7): e0235897, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32649680

RESUMO

BACKGROUND/OBJECTIVES: To investigate the potential utility of MNREAD acuity charts and contrast/glare sensitivity (CGS) assessment for evaluating the efficacy of an initial treatment with ranibizumab (Lucentis®) for branch retinal vein occlusion (BRVO). METHODS: Intravitreal injections of ranibizumab were administered in 43 eyes of 43 treatment-naïve patients with BRVO. Efficacy was assessed 1 month later. Best-corrected far/near visual acuity (BCFVA/BCNVA), MNREAD parameters (reading acuity [RA], maximum reading speed [MRS], critical print size [CPS]), CGS (CS/GS), and central macular thickness (CMT) in optical coherence tomography (OCT) before and after treatment were evaluated. The area (superior/inferior) affected by BRVO was determined by fluorescein angiography. RESULTS: All parameters improved significantly following treatment (p < 0.05), and all MNREAD and CGS parameters were significantly correlated with BCVA in the treated eye before and after treatment (p < 0.01). The changes in BCFVA, BCNVA, MRS, and CS were significantly correlated with the amount of change in CMT (p < 0.007; r = 0.415, 0.528, -0.465, and -0.508, respectively). MRS exhibited a percentage change that was significantly correlated with that in CMT (p < 0.007; r = -0.511). Additionally, MRS exhibited the lowest threshold CMT (397 µm) at which the most significant change in improvement was observed. CMT was less likely to improve if BRVO occurred at a superior site than if it occurred at an inferior site (0.05 < p = 0.07 < 0.1). CONCLUSIONS: MNREAD and CGS testing were useful for evaluating BRVO treatment efficacy. MRS might be a valuable index for evaluating treatment success and making treatment decisions.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Ranibizumab/uso terapêutico , Oclusão da Veia Retiniana/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Feminino , Ofuscação , Humanos , Macula Lutea/diagnóstico por imagem , Macula Lutea/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Oclusão da Veia Retiniana/diagnóstico por imagem , Tomografia de Coerência Óptica , Acuidade Visual/efeitos dos fármacos
13.
PLoS One ; 15(6): e0235213, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32579608

RESUMO

PURPOSE: To compare the 1-year visual outcomes and anatomical responses of patients who received photodynamic therapy (PDT) combined with intravitreal ranibizumab (IVR) injections with those of patients who received PDT combined with intravitreal aflibercept (IVA) injections for treating polypoidal choroidal vasculopathy (PCV). METHODS: We retrospectively studied all treatment-naïve patients with PCV who received PDT combined with either IVR or IVA. Best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), the number of additional injections, and the presence of polypoidal lesions, as indicated by indocyanine green angiography (ICGA), during 1 year were evaluated. RESULTS: Forty-four eyes were assessed at the 1-year follow-up examination. Of these, 23 were treated with PDT combined with IVR (PDT/IVR group), and 21 were treated with PDT combined with IVA (PDT/IVA group). In both groups, BCVA was shown to be significantly improved 1 year after the initial treatment. CMT and CCT were also significantly decreased after 1 year. There were no significant differences in the changes in BCVA or CMT between the two groups. However, the change in CCT in the PDT/IVA group was significantly larger than that of the PDT/IVR group (P < 0.001). The mean number of additional injections was 0.78 ± 0.21 in the PDT/IVR group and 0.57 ± 0.21 in the PDT/IVA group with no significant difference between the two groups (P = 0.45). The polyp regression rate at 12 months was 78.2% in the PDT/IVR group and 78.9% in the PDT/IVA group with no significant difference between the two groups. CONCLUSIONS: PDT combined with either IVR or IVA was well tolerated and appeared to improve both vision and anatomy in patients with PCV. PDT/IVA may have a more pronounced effect on macular choroidal thickness at 1-year follow-up.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Doenças da Coroide/tratamento farmacológico , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Corioide/fisiologia , Doenças da Coroide/patologia , Terapia Combinada , Feminino , Angiofluoresceinografia , Humanos , Injeções Intravítreas , Lasers , Masculino , Pessoa de Meia-Idade , Fotoquimioterapia , Fármacos Fotossensibilizantes/uso terapêutico , Estudos Retrospectivos , Verteporfina/uso terapêutico , Acuidade Visual
14.
PLoS One ; 15(6): e0233595, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32492069

RESUMO

PURPOSE: To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. PATIENTS AND METHODS: A 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (≥18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (≤4 and ≥5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients. RESULTS: Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections. Presented by injection frequencies ≤4 and ≥5, VA letter score gains were 0.5 (n = 264) and 6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively. No endophthalmitis cases were reported. CONCLUSIONS: The LUMINOUS study included patients with DME with more diverse baseline characteristics than those in randomized clinical trials. The 1-year data showed improvement in VA with low number of injections in treatment- naïve patients with DME. Greater VA gains were observed in patients who received ≥5 injections. No new safety findings were identified. LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of patients with DME in a real-world clinical practice.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Retinopatia Diabética/complicações , Retinopatia Diabética/tratamento farmacológico , Edema Macular/complicações , Edema Macular/tratamento farmacológico , Ranibizumab/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Feminino , Seguimentos , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ranibizumab/administração & dosagem , Ranibizumab/efeitos adversos , Resultado do Tratamento , Acuidade Visual/efeitos dos fármacos
15.
Digit J Ophthalmol ; 26(1): 1-7, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32547330

RESUMO

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.


Assuntos
Neovascularização de Coroide/tratamento farmacológico , Angiofluoresceinografia , Fotoquimioterapia , Fármacos Fotossensibilizantes/uso terapêutico , Tomografia de Coerência Óptica , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Inibidores da Angiogênese/uso terapêutico , Neovascularização de Coroide/diagnóstico por imagem , Quimioterapia Combinada , Feminino , Fóvea Central , Humanos , Injeções Intravítreas , Ranibizumab/uso terapêutico , Líquido Sub-Retiniano , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Degeneração Macular Exsudativa/diagnóstico por imagem
16.
PLoS One ; 15(6): e0234739, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32555630

RESUMO

OBJECTIVE: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in treatment-naïve patients with branch retinal vein occlusion (BRVO) enrolled in the LUMINOUS™ study. STUDY DESIGN: A 5-year, global, prospective, multicenter, observational, open-label study conducted in a clinical practice (real-world) setting at outpatient ophthalmology clinics that recruited 30,138 consenting adult patients from all approved indications for ranibizumab across 42 countries. Patients with BRVO were treated according to the local ranibizumab label of the participating countries. Mean change in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study letters from baseline to Year 1, treatment exposure during Year 1, and adverse events (AEs) over 5 years were assessed. RESULTS: Of the 1366 recruited BRVO patients, 405 were treatment-naïve at baseline with a mean (standard deviation [SD]) age of 67.9 (12.5) years, 57.5% were female, and 71.8% were White. At Year 1 (n = 189), the mean (SD) VA gain was 11.9 (17.66) letters from a baseline of 49.2 (±20.32) letters with a mean (SD) of 5.0 (2.34) injections. VA gains were higher in patients (n = 83) who received 6-9 injections (13.6 [20.16] letters) than in those who received 2-5 injections (n = 92, 11.7 [15.43] letters), or 1 injection (n = 14, 3.6 [13.72] letters). Patients with baseline VA <23 letters had numerically highest VA gains (n = 20, 31.1 [24.48] letters). Over 5 years, the rate of ocular/non-ocular AEs was 7.4%/9.1% and serious AEs was 0.3%/4.4% in treatment-naïve BRVO patients (n = 405). CONCLUSIONS: One year results from the LUMINOUS real-world study showed a clinically meaningful VA improvement with ranibizumab in treatment-naïve patients with BRVO; numerically higher VA gains were achieved in patients who received more injections and those with poor baseline VA. No new safety signals were observed.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Ranibizumab/uso terapêutico , Oclusão da Veia Retiniana/tratamento farmacológico , Idoso , Inibidores da Angiogênese/efeitos adversos , Conjuntivite/etiologia , Feminino , Humanos , Pressão Intraocular , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ranibizumab/efeitos adversos , Resultado do Tratamento , Acuidade Visual
17.
Am J Ophthalmol ; 218: 225-241, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32565050

RESUMO

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.


Assuntos
Inibidores da Angiogênese/economia , Neovascularização de Coroide/economia , Análise Custo-Benefício , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Fator A de Crescimento do Endotélio Vascular/economia , Degeneração Macular Exsudativa/economia , Idoso , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/economia , Bevacizumab/uso terapêutico , Neovascularização de Coroide/tratamento farmacológico , Custos de Medicamentos , Feminino , Custos de Cuidados de Saúde , Humanos , Injeções Intravítreas , Masculino , Medicare , Anos de Vida Ajustados por Qualidade de Vida , Ranibizumab/economia , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/economia , Proteínas Recombinantes de Fusão/uso terapêutico , Estados Unidos , Acuidade Visual , Degeneração Macular Exsudativa/tratamento farmacológico
18.
Medicine (Baltimore) ; 99(21): e20222, 2020 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-32481293

RESUMO

BACKGROUND: The objective of this review and meta-analysis is to investigate the efficacy of conbercept and ranibizumab, combined with or without laser photocoagulation, in patients with macular edema secondary to retinal vein occlusion (RVO-ME). METHODS: Several databases have been used to identify relevant publications. After screening, a meta-analysis was conducted to compare conbercept and ranibizumab with the support of RevMan 5.3 (Cochrane Library Software, Oxford, UK). RESULTS: In this study, 9 randomized controlled trials and 6 retrospective trials were included with a total of 1180 patients. No significant difference was found in best corrected visual acuity (BCVA) or central macular thickness (CMT) in the baseline parameters [BCVA (weighted mean difference (WMD): -0.01; 95% confidence interval CI: -0.03 to 0.01; P = .17), CMT (WMD: 20.14; 95% CI: -26.70 to 66.97; P = .40). No significant differences were found in the improvements of BCVA and adverse events (AEs) between the 2 groups after injection of loading dosage [the 1st month BCVA (WMD: -0.01; 95% CI: -0.04 to 0.02; P = .54),the 3rd month BCVA (WMD: -0.02; 95% CI: --0.05 to 0.01; P = .23), the 6th month BCVA (WMD: -0.02; 95% CI: -0.05 to 0.01; P = .27), AEs (odds ratio: 0.84; 95% CI: 0.38 to 1.84; P = .66)]. However, there were significant differences between conbercept and ranibizumab treatment in terms of CMT [1st month CMT (WMD: -11.70; 95% CI: -19.71 to -3.68; P < .01), 3rd month CMT (WMD: -10.08; 95% CI: -15.62 to -4.53; P < .01), 6th month CMT (WMD: -15.83; 95% CI: -22.88 to -8.78; P < .01)] and the number of injections (WMD, -0.36; 95% CI: -0.68 to -0.04; P = .03). CONCLUSION: The current pooled evidence suggested that both therapies of intravitreal conbercept and intravitreal ranibizumab with or without laser photocoagulation are effective in vision function in RVO-ME patients, and confirmed that conbercept has advantages over ranibizumab in terms of CMT and the number of injections for treating RVO-ME. In addition, conbercept has the statistically same visual gains and safety as ranibizumab in RVO-ME patients. Longer-term follow-up surveys on the safety and effectiveness of these 2 treatment regimens are required.


Assuntos
Fotocoagulação/métodos , Edema Macular/tratamento farmacológico , Edema Macular/terapia , Oclusão da Veia Retiniana/complicações , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/uso terapêutico , Terapia Combinada/métodos , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico por imagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Ranibizumab/administração & dosagem , Ranibizumab/efeitos adversos , Ranibizumab/uso terapêutico , Proteínas Recombinantes de Fusão/administração & dosagem , Proteínas Recombinantes de Fusão/efeitos adversos , Proteínas Recombinantes de Fusão/uso terapêutico , Estudos Retrospectivos , Tomografia de Coerência Óptica , Acuidade Visual/efeitos dos fármacos
19.
Arch. Soc. Esp. Oftalmol ; 95(6): 279-283, jun. 2020. ilus, graf
Artigo em Espanhol | IBECS | ID: ibc-199193

RESUMO

CASO CLÍNICO: Paciente de 14 años de edad concurre refiriendo una disminución progresiva de la agudeza visual del ojo izquierdo de 3 meses de evolución. Al examen presenta drusas de papila bilateral, asociadas a membrana neovascular yuxtapapilar, que comprometen seriamente la visión y el campo visual del ojo izquierdo. RESULTADO: El tratamiento con 3 inyecciones consecutivas de ranibizumab intravítreo resultó en la inactivación de la membrana neovascular con reabsorción de líquido subretiniano y mejora de la agudeza visual mejor corregida del ojo izquierdo. Después de 9 meses de seguimiento, esta fue 20/20 y estable. CONCLUSIÓN: Si bien las drusas de la cabeza del nervio óptico son consideradas benignas, las membranas neovasculares pueden ser una complicación. Los anti-VEGF son una alternativa eficaz para el tratamiento


CLINICAL CASE: Forteen year old patient presenting progressive decrease in visual acuity of the left eye after 3 months of evolution. On examination he presents bilateral drusen of papilla, associated with juxtapapillary neovascular membrane, which seriously compromises the vision and visual field of the left eye. RESULT: Treatment with 3 consecutive injections of intravitreal ranibizumab resulted in the inactivation of the neovascular membrane with reabsorption of subretinal fluid and improvement of the best corrected visual acuity of the left eye. After 9 months of follow-up, it was 20/20 and stable. CONCLUSION: Although optic nerve head drusen are considered benign, neovascular membranes can be a complication. Anti-VEGFs are an effective alternative for treatment


Assuntos
Humanos , Adolescente , Drusas do Disco Óptico/etiologia , Membranas/fisiopatologia , Neovascularização Patológica/complicações , Drusas do Disco Óptico/diagnóstico por imagem , Papiledema/complicações , Papiledema/diagnóstico por imagem , Acuidade Visual , Fundo de Olho , Ultrassonografia , Tomografia de Coerência Óptica , Ranibizumab/uso terapêutico , Inibidores da Angiogênese/uso terapêutico , Drusas do Disco Óptico/tratamento farmacológico , Papiledema/tratamento farmacológico
20.
PLoS One ; 15(5): e0232353, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32369500

RESUMO

IMPORTANCE: Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness with several intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents available for its management such as aflibercept, bevacizumab, and ranibizumab. However, direct comparisons between these three agents among the same patient population are limited. OBJECTIVE: To assess the rate and growth of complete retinal pigment epithelium and outer retinal atrophy (cRORA) in eyes with nAMD treated with aflibercept, bevacizumab, and/or ranibizumab. METHOD: Retrospective cohort study of patients with treatment-naïve neovascular AMD seen at an academic hospital between October 2006 and February 2019. Study eyes were treated with intravitreal injections of aflibercept, bevacizumab, and/or ranibizumab and followed for two years. MAIN OUTCOMES AND MEASURES: cRORA prevalence, location, size, and growth rate. Eyes were imaged with Cirrus spectral domain optical coherence tomography (SD-OCT). Presence and size of cRORA were calculated using the FDA-approved Advanced RPE Analysis software. Linear regression models were used to correlate cRORA progression with baseline demographic and ocular characteristics, anti-VEGF drug, and number of injections. Unpaired t-tests, ANOVA, and linear regression models were computed with SAS 9.4. RESULTS: 197 eyes from 158 patients (mean age 78.9, 62.9% women) received an average of 13 anti-VEGF injections over 24 months. 22% developed new cRORA. Mean cRORA area increased from 1.71 mm2 to 2.93 mm2. At 24 months, eyes with 11+ injections had significantly less cRORA area (11+ injections, 4.02 mm2; ≤ 10 injections, 2.46 mm2; p = 0.01) and growth rate (11+ injections, 0.41 mm2/year; ≤ 10 injections, 1.05 mm2/year; p = 0.02). Choice of anti-VEGF drug yielded no significant difference in cRORA progression. CONCLUSIONS AND RELEVANCE: Treating nAMD with aflibercept, bevacizumab or ranibizumab demonstrated comparable cRORA development at 24 months. Number of injections inversely correlated with cRORA area and growth. These results warrant further investigation in the pathophysiology of cRORA in anti-VEGF treated eyes.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Degeneração Retiniana/tratamento farmacológico , Degeneração Retiniana/patologia , Epitélio Pigmentado da Retina/efeitos dos fármacos , Epitélio Pigmentado da Retina/patologia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Atrofia , Bevacizumab/uso terapêutico , Feminino , Seguimentos , Humanos , Interpretação de Imagem Assistida por Computador , Injeções Intravítreas , Masculino , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Degeneração Retiniana/diagnóstico por imagem , Epitélio Pigmentado da Retina/diagnóstico por imagem , Estudos Retrospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento
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