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1.
Klin Monbl Augenheilkd ; 237(11): 1320-1325, 2020 Nov.
Artigo em Inglês, Alemão | MEDLINE | ID: mdl-33202460

RESUMO

Using mobile OCT equipment and remote ophthalmological diagnosis of n = 1538 diabetics in 17 diabetes practices in Germany, we found diabetic macular edema in 10.1% of the patients and retinal bleedings or microaneurysms in 15.6%. In 1.62% of the diabetics examined, the size of the edema was > 0.4 mm², in 7% the retinal thickness was > 300 µm and thus in need of treatment. An intravitreal anti-VEGF injection was administered prior to the examination in only 10% of the patients with diabetic macular edema. By means of mobile tele-eye consultation and remote ophthalmological diagnosis using the cloud-based patient file certified as medical device IIa, patients with diabetic macular edema were identified and informed on site quickly and definitively. The data and images were made available to all attending physicians and ophthalmic surgeons.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/terapia , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/terapia , Retina , Tomografia de Coerência Óptica
2.
Cesk Slov Oftalmol ; 1(Ahead of print): 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
3.
Medicine (Baltimore) ; 99(38): e22267, 2020 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-32957378

RESUMO

BACKGROUND: Multiple intravitreal pharmacotherapies including different anti-vascular endothelial growth factors (VEGF), intravitreal steroids, and combined therapy with anti-VEGF and steroids are available for patients with macular edema secondary to retinal vein occlusion (RVO). However, the recommendation of multiple therapies remains unknown. This study aims to evaluate the efficacy and safety of multiple intravitreal pharmacotherapies in patients with macular edema secondary to RVO. METHODS: We will systematically search the PubMed, Embase, and the Cochrane library for eligible studies. Randomized controlled trials (RCTs) with intravitreal pharmacotherapies for patients with macular edema secondary to RVO will be included. The Cochrane Collaboration's tool will be used to assess the risk of bias in the randomized trial. The primary outcome is the mean change in BCVA from baseline. The secondary outcomes are the proportion of patients who gained ≥15 letters in BCVA from baseline, the mean change in central retinal thickness from baseline and the number of serious adverse events. RESULTS: The result will obtain a comprehensive treatment recommendation for macular edema secondary to RVO. CONCLUSION: The results of the network meta-analysis will be submitted in a peer-reviewed journal for publication. ETHICAL STATEMENT: This article does not contain any studies with human or animal subjects performed by any of the authors.


Assuntos
Edema Macular/tratamento farmacológico , Metanálise em Rede , Oclusão da Veia Retiniana/complicações , Revisões Sistemáticas como Assunto , Humanos , Injeções Intravítreas , Edema Macular/etiologia
4.
Medicine (Baltimore) ; 99(35): e21992, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871950

RESUMO

BACKGROUND: Diabetic macular edema (DME) can cause severe vision impairments for patients with diabetes. Recently, Conbercept has shown efficacy on DME with 3-monthly loading dose injection and pro re nata (PRN, 3+PRN) thereafter in retrospectivetrials. Furthermore, there are some other approaches have been recommended such as 2mg bimonthly (2q8) after 5 initial doses, or Conbercept 0.5mg treat-and-extend, however, some patients still have recurrence of the disease after treatment. Therefore, in order to identify more efficacy and safety approach on Conbercept inpatients with DME, a randomized controlled trial will be performed with 6-monthly loading dose injection and PRN (6+PRN) compared with 3+PRN treatments. METHODS: This study is a multicenter, randomized control trial of Conbecept treating DME in China. Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited. All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment. RESULTS: This study will provide a new powerful evidence of the efficacy and safety of Conbecept treating DME. DISCUSSION: This RTC study will determine whether multiple treatments of Conbercept provide better effectiveness in patients with DME. TRIAL REGISTRATION NUMBER: ChiCTR2000032728.


Assuntos
Retinopatia Diabética/tratamento farmacológico , Edema Macular/tratamento farmacológico , Proteínas Recombinantes de Fusão/uso terapêutico , Angiografia , Estudos de Equivalência como Asunto , Humanos , Estudos Multicêntricos como Assunto , Tomografia de Coerência Óptica
5.
Vestn Oftalmol ; 136(4. Vyp. 2): 289-295, 2020.
Artigo em Russo | MEDLINE | ID: mdl-32880153

RESUMO

Postsurgical macular edema, known as Irvine-Gass syndrome, is one of the possible causes of reduced visual acuity in ophthalmic surgery. The article reviews and summarizes data on the main approaches to the treatment of this pathology, discusses the main groups of drugs used to manage postoperative macular edema.


Assuntos
Extração de Catarata , Edema Macular/tratamento farmacológico , Humanos , Injeções Intravítreas , Acuidade Visual , Vitrectomia
6.
Value Health ; 23(7): 928-935, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32762995

RESUMO

OBJECTIVES: Mappings to convert clinical measures to preference-based measures of health such as the EQ-5D-3L are sometimes required in cost-utility analyses. We developed mappings to convert best-corrected visual acuity (BCVA) to the EQ-5D-3L, the EQ-5D-3L with a vision bolt-on (EQ-5D V), and the Visual Functioning Questionnaire-Utility Index (VFQ-UI) in patients with macular edema caused by central retinal vein occlusion. METHODS: We used data from Lucentis, Eylea, Avastin in vein occlusion (LEAVO), which is a phase-3 randomized controlled trial comparing ranibizumab, aflibercept, and bevacizumab in 463 patients with observations at 6 time points. We estimated adjusted limited dependent variable mixture models consisting of 1 to 4 distributions (components) using BCVA in each eye, age, and sex to predict utility within the components and BCVA as a determinant of component membership. We compared model fit using mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions. RESULTS: Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI. The best-fitting models for the EQ-5D and EQ-5D V had 2 components (with means of approximately 0.44 and 0.85), and the best-fitting model for VFQ-UI had 3 components (with means of approximately 0.95, 0.74, and 0.90). CONCLUSIONS: Models with multiple components better predict utility than those with single components. This article provides a valuable addition to the literature, in which previous mappings in visual acuity have been limited to linear regressions, resulting in unfounded assumptions about the distribution of the dependent variable.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Edema Macular/tratamento farmacológico , Inquéritos e Questionários , Acuidade Visual/efeitos dos fármacos , Adulto , Idoso , Idoso de 80 Anos ou mais , Bevacizumab/administração & dosagem , Feminino , Humanos , Edema Macular/etiologia , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Preferência do Paciente , Qualidade de Vida , Ranibizumab/administração & dosagem , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Oclusão da Veia Retiniana/complicações , Adulto Jovem
7.
J Fr Ophtalmol ; 43(8): 710-717, 2020 Oct.
Artigo em Francês | MEDLINE | ID: mdl-32653096

RESUMO

Initial management of diabetic macular edema (DME) is well-defined, but there is a lack of national or international consensus for patients who do not respond or respond only partially to these treatments. Several studies, mostly retrospective, have assessed medication switches, but currently, the literature contains no randomized studies. The goal of this article is to present an algorithm for switching medications, which can be proposed to DME patients treated with anti-VEGF agents, as defined by a group of French retina experts, supported by the existing literature on the subject. After initiation of an anti-VEGF treatment for DME, the response is usually assessed after 5 monthly injections. A partial anatomical response (reduction of central retinal thickness between 10 and 20%), seen in 30 to 40% of patients, is associated with a favorable visual prognosis according to randomized studies. Continuation of the anti-VEGF injections after the induction phase is thus possible. If the response remains incomplete after 3 additional anti-VEGF injections, a complete ophthalmologic examination should be performed, and a switch to another therapeutic class (corticosteroids) may be proposed in the absence of contraindications. If a complete non-response is seen initially (reduction of central retinal thickness<10%), the switch is proposed immediately after the induction phase.


Assuntos
Algoritmos , Retinopatia Diabética/tratamento farmacológico , Substituição de Medicamentos/normas , Edema Macular/tratamento farmacológico , Guias de Prática Clínica como Assunto , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Bevacizumab/administração & dosagem , Bevacizumab/efeitos adversos , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Retinopatia Diabética/epidemiologia , Substituição de Medicamentos/métodos , Substituição de Medicamentos/estatística & dados numéricos , Humanos , Injeções Intravítreas , Edema Macular/epidemiologia , Ranibizumab/administração & dosagem , Ranibizumab/efeitos adversos , Estudos Retrospectivos
9.
Graefes Arch Clin Exp Ophthalmol ; 258(12): 2639-2645, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32712708

RESUMO

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.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Acesso aos Serviços de Saúde , Edema Macular/tratamento farmacológico , Pneumonia Viral/epidemiologia , Oclusão da Veia Retiniana/tratamento farmacológico , Degeneração Macular Exsudativa/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Neovascularização de Coroide/tratamento farmacológico , Feminino , Prioridades em Saúde , Pesquisa sobre Serviços de Saúde , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Pandemias , Quarentena/estatística & dados numéricos , Estudos Retrospectivos , Reino Unido/epidemiologia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade Visual/fisiologia , Adulto Jovem
10.
Cochrane Database Syst Rev ; 7: CD009510, 2020 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-32633861

RESUMO

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.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Edema Macular/tratamento farmacológico , Oclusão da Veia Retiniana/complicações , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Bevacizumab/administração & dosagem , Humanos , Injeções Intravítreas , Fotocoagulação a Laser , Terapia a Laser , Edema Macular/etiologia , Edema Macular/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Ranibizumab/administração & dosagem , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Terapia de Salvação/métodos , Esteroides/administração & dosagem , Acuidade Visual/efeitos dos fármacos
11.
J Fr Ophtalmol ; 43(7): 618-625, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32473741

RESUMO

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.


Assuntos
Bevacizumab/administração & dosagem , Retinopatia Diabética/tratamento farmacológico , Edema Macular/tratamento farmacológico , Centros Médicos Acadêmicos , Idoso , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Bevacizumab/efeitos adversos , Retinopatia Diabética/epidemiologia , Feminino , Seguimentos , França/epidemiologia , Humanos , Injeções Intravítreas , Edema Macular/epidemiologia , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Sistema de Registros , Estudos Retrospectivos , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Fator A de Crescimento do Endotélio Vascular/imunologia
12.
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
13.
Medicine (Baltimore) ; 99(21): e20173, 2020 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-32481287

RESUMO

INTRODUCTION: Retinal vein occlusion refers to diseases with decreased vision, dilated tortuous retinal veins visible on the fundus, and retinal hemorrhage, edema, and osmosis distributed along the vein. There is still no ideal intervention to treat central retinal vein occlusion. This study plan to observe the efficacy of Dan-Hong Hua-Yu oral solution in treating non-ischemic retinal vein occlusion, in order to provide new treatment ideas. METHODS/DESIGN: We plan to use random number table method, 64 cases of non-ischemic central retinal vein occlusion that meet the inclusion criteria will be randomly divided into a treatment group and a control group. The intervention group will be treated with Dan-Hong Hua-Yu oral solution according to the syndrome differentiation of Traditional Chinese medicine and the patient's fundus condition. Each group will take 4 weeks as a course of treatment and three consecutive courses of treatment without any interval during the course of treatment. Changes of visual acuity, fundus performance, and total clinical symptoms of patients before and after treatment will be observed. DISCUSSION: This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000030625, Registered on March 08, 2020.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Edema Macular/tratamento farmacológico , Oclusão da Veia Retiniana/tratamento farmacológico , Administração Oral , Adulto , Idoso , Estudos de Casos e Controles , China/epidemiologia , Medicamentos de Ervas Chinesas/administração & dosagem , Feminino , Angiofluoresceinografia/métodos , Fundo de Olho , Humanos , Edema Macular/diagnóstico por imagem , Edema Macular/patologia , Masculino , Pessoa de Meia-Idade , Oclusão da Veia Retiniana/diagnóstico por imagem , Oclusão da Veia Retiniana/patologia , Acuidade Visual/efeitos dos fármacos
14.
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
15.
Sci Rep ; 10(1): 7299, 2020 04 29.
Artigo em Inglês | MEDLINE | ID: mdl-32350366

RESUMO

Diabetic macular edema (DME) refractory to anti-VEGF drugs is a socioeconomic burden. In this retrospective study, we investigated the relationship between DME remission and hyperreflective walls in foveal cystoid spaces, a novel finding on spectral domain optical coherence tomography (SD-OCT) images in DME. In a cross-sectional study, we assessed the relationship between hyperreflective walls in foveal cystoid spaces and other OCT findings in 110 eyes of 110 DME patients. Hyperreflective walls were delineated in 27 of 171 foveal cystoid spaces. Eyes with hyperreflective walls in foveal cystoid spaces had poorer visual acuity and more severe photoreceptor disruption than did those without such findings (P = 0.008 and P < 0.001, respectively). In the other longitudinal study, we evaluated the relationship between this finding and the remission in 54 eyes of 51 DME patients treated with as-needed ranibizumab injections for 24 months. Foveal cystoid spaces with hyperreflective walls were often persistent, and the cumulative rates of DME remission among eyes with and without the hyperreflective walls were 7.7% (1 eye) and 48.8% (20 eyes) at 18 months (hazard ratio, 0.092; P = 0.025). We characterized hyperreflective walls in foveal cystoid spaces and designated them as a predictor of no DME remission under ranibizumab injections.


Assuntos
Retinopatia Diabética , Resistência a Medicamentos/efeitos dos fármacos , Fóvea Central/diagnóstico por imagem , Edema Macular , Ranibizumab/administração & dosagem , Tomografia de Coerência Óptica , Adulto , Idoso , Biomarcadores , Estudos Transversais , Retinopatia Diabética/diagnóstico por imagem , Retinopatia Diabética/tratamento farmacológico , Feminino , Humanos , Edema Macular/diagnóstico por imagem , Edema Macular/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
16.
Am J Ophthalmol ; 218: 59-67, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32360340

RESUMO

PURPOSE: To describe the pre-exudative stage of exudative perifoveal vascular anomalous complex (ePVAC), referred to as nonexudative PVAC (nePVAC). DESIGN: Retrospective noncomparative case series. METHODS: Patients diagnosed with nePVAC were identified at 4 retina referral centers worldwide. Multimodal retinal imaging, including structural optical coherence tomography (OCT) and OCT-angiography (OCT-A), were performed at baseline and follow-up visits. RESULTS: Six eyes (6 patients, mean 75 ± 10 years of age) were included. Unrelated chorioretinal diseases were diagnosed in the affected eyes in 5 of 6 cases. At baseline, nePVAC is characterized by microvascular abnormalities featuring an isolated, perifoveal, large intraretinal aneurysm surrounded by capillary rarefaction at OCT-A examination, without any sign of exudation with structural OCT, and without visual impairment. Four patients were followed for a mean of 21 ± 14 months. During the follow-up, 3 of 4 eyes (75%) developed signs of exudation after a mean of 15 ± 9 months, associated with metamorphopsia and visual decline at the time of exudation. Best-corrected visual acuity decreased from 20/25 to 20/40 Snellen equivalent (P = .035) and central macular thickness increased from 268 ± 27 µm to 339 ± 65 µm (P = .145). Three patients were treated with 2.3 ± 0.6 intravitreal injections of anti-vascular endothelial growth factor without significant improvement of best-corrected visual acuity or macular edema. CONCLUSIONS: nePVAC may represent the subclinical pre-exudative stage of ePVAC, notable for an absence of exudation or visual impairment. nePVAC and ePVAC should be considered as part of the same spectrum, namely PVAC. Typically, nePVAC develops signs of exudation over time, causing metamorphopsia and visual decline and therefore these lesions warrant continued close monitoring with multimodal retinal imaging.


Assuntos
Fóvea Central/irrigação sanguínea , Degeneração Macular/diagnóstico , Edema Macular/diagnóstico , Macroaneurisma Arterial Retiniano/diagnóstico , Malformações Vasculares/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/uso terapêutico , Exsudatos e Transudatos , Feminino , Angiofluoresceinografia , Humanos , Injeções Intravítreas , Degeneração Macular/tratamento farmacológico , Degeneração Macular/fisiopatologia , Edema Macular/tratamento farmacológico , Edema Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Imagem Multimodal , Macroaneurisma Arterial Retiniano/tratamento farmacológico , Macroaneurisma Arterial Retiniano/fisiopatologia , Estudos Retrospectivos , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Malformações Vasculares/tratamento farmacológico , Malformações Vasculares/fisiopatologia , Acuidade Visual/fisiologia
17.
Acta Diabetol ; 57(10): 1193-1201, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32367246

RESUMO

AIMS: To compare the long-term functional and anatomical outcomes of cataract surgery with combined versus 1-month deferred intravitreal dexamethasone implant (DEX) in eyes with pre-existing diabetic macular edema (DME). METHODS: Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were retrospectively evaluated in both groups before treatments, then 1, 4, 12 and 24 months after DEX. RESULTS: Forty eyes were analyzed, 20 in each group. BCVA disclosed comparable trends, increasing from similar starting values (p = 0.9913) to akin scores 1 month after DEX (p = 0.4229). After 4 months, it similarly reduced without significant variations within each group throughout the whole observation period. CRT was similar at the time of surgery (p = 0.6134) and was reduced by DEX injection in both samples, with a superior beneficial effect in the combined group after 1 month (p = 0.0010). At 4 months, CRT further elevated and remained overall stable in the long term without differences. By 12 months, 19 (95%) eyes received further injections: 1 (5%) fluocinolone, 3 (15%) received other DEX and fluocinolone, 13 (65%) ≥ 1 DEX only and 2 (10%) anti-VEGFs. During the second year, 6 additional eyes (from the 13 receiving DEX) switched to fluocinolone, reaching a total of 10 (50%). Similar results were observed in the deferred group. CONCLUSIONS: DEX implant performed at the time of surgery achieved the same long-term functional and anatomical outcomes compared to a 1-month injection deferral in treating eyes with pre-existing DME that should undergo cataract extraction.


Assuntos
Extração de Catarata/métodos , Dexametasona/administração & dosagem , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/cirurgia , Edema Macular/tratamento farmacológico , Edema Macular/cirurgia , Idoso , Catarata/complicações , Catarata/tratamento farmacológico , Extração de Catarata/efeitos adversos , Terapia Combinada , Dexametasona/efeitos adversos , Esquema de Medicação , Implantes de Medicamento , Feminino , Glucocorticoides/administração & dosagem , Glucocorticoides/uso terapêutico , Humanos , Injeções Intravítreas , Edema Macular/complicações , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Acuidade Visual
18.
Acta Diabetol ; 57(10): 1219-1225, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32472172

RESUMO

AIMS: To compare intravitreal ranibizumab as monotherapy or in combination with panretinal photocoagulation (PRP) in patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME) in a long-term follow-up of 24 months. METHODS: Participants in this prospective study were 47 patients with PDR and concurrent DME, who were randomized at baseline into two groups: (i) the "ranibizumab alone" group (n = 23), which was treated with at least 3 intravitreal ranibizumab injections as a loading phase, and (ii) the "combination" group (n = 24), which was treated with PRP and at least 3 intravitreal ranibizumab injections. Thereafter, all patients were followed up at a pro re nata (PRN) basis, with regular monthly monitoring for 24 months. At each visit, best corrected visual acuity (BCVA) and spectral domain-optical coherence tomography were performed, while regression of neovascularization was also recorded. RESULTS: The "combination" group had better control of neovascularization and less events of vitreous hemorrhage than ranibizumab alone through the 2 years. BCVA did not differ significantly between the two groups at months 12 and 24 of the follow-up. The "ranibizumab" alone group presented greater reduction in central retinal thickness at month 12, which did not reach significance at month 24 compared to "combination" group. Greater number of injections was needed in the monotherapy group (mean 14 injections) compared to "combination" group (mean 11 injections) through month 24. CONCLUSIONS: Both intravitreal ranibizumab alone or in combination with PRP could be used effectively for the treatment of PDR and coexistent DME. Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.


Assuntos
Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/cirurgia , Fotocoagulação a Laser/métodos , Edema Macular/tratamento farmacológico , Edema Macular/cirurgia , Ranibizumab/administração & dosagem , Idoso , Inibidores da Angiogênese/administração & dosagem , Terapia Combinada , Retinopatia Diabética/complicações , Feminino , Humanos , Injeções Intravítreas , Fotocoagulação a Laser/efeitos adversos , Edema Macular/complicações , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ranibizumab/efeitos adversos , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular , Acuidade Visual , Vitreorretinopatia Proliferativa/complicações , Vitreorretinopatia Proliferativa/tratamento farmacológico , Vitreorretinopatia Proliferativa/cirurgia
19.
PLoS One ; 15(4): e0232494, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32353052

RESUMO

BACKGROUND AND OBJECTIVE: To develop a semi-automated, machine-learning based workflow to evaluate the ellipsoid zone (EZ) assessed by spectral domain optical coherence tomography (SD-OCT) in eyes with macular edema secondary to central retinal or hemi-retinal vein occlusion in SCORE2 treated with anti-vascular endothelial growth factor agents. METHODS: SD-OCT macular volume scans of a randomly selected subset of 75 SCORE2 study eyes were converted to the Digital Imaging and Communications in Medicine (DICOM) format, and the EZ layer was segmented using nonproprietary software. Segmented layer coordinates were exported and used to generate en face EZ thickness maps. Within the central subfield, the area of EZ defect was measured using manual and semi-automated approaches via a customized workflow in the open-source data analytics platform, Konstanz Information Miner (KNIME). RESULTS: A total of 184 volume scans from 74 study eyes were analyzed. The mean±SD area of EZ defect was similar between manual (0.19±0.22 mm2) and semi-automated measurements (0.19±0.21 mm2, p = 0.93; intra-class correlation coefficient = 0.90; average bias = 0.01, 95% confidence interval of limits of agreement -0.18-0.20). CONCLUSIONS: A customized workflow generated via an open-source data analytics platform that applied machine-learning methods demonstrated reliable measurements of EZ area defect from en face thickness maps. The result of our semi-automated approach were comparable to manual measurements.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Monitoramento de Medicamentos/métodos , Aprendizado de Máquina , Edema Macular/diagnóstico , Oclusão da Veia Retiniana/tratamento farmacológico , Adulto , Bevacizumab/uso terapêutico , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Macula Lutea/diagnóstico por imagem , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Oclusão da Veia Retiniana/complicações , Tomografia de Coerência Óptica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Fluxo de Trabalho
20.
Acta Diabetol ; 57(9): 1081-1091, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32274583

RESUMO

AIMS: Clinical outcomes of diabetic macular edema (DME) have been widely described, but data on diabetic retinopathy perceptions by diabetes patients are limited. The aim of this survey was to explore the lived experience, knowledge, fears and expectations about disease, and treatment in patients with diabetes and macular edema treated with intravitreal injections (IVTI) and to characterize patient profiles. METHODS: Cross-sectional survey including a preliminary qualitative phase (20 patients with DME, treated or treatment-naive, 5 female and 15 male, age 36-74 years) followed by a quantitative survey (116 patients treated with IVTI for DME). Data ASKIA Analyze (version 5.3.3.5) was used for descriptive statistics, and R software (version 3.4.1) for multiple correspondence analysis. RESULTS: The qualitative phase identified the wording used by patients and information helpful to propose modalities of response in the quantitative phase. In the quantitative survey (116 patients, mean age 66.6 years), most patients were treated with anti-vascular endothelial growth factor. Overall, 71.9% reported that the disease negatively affected their daily activities and 33.1% considered that regular visits to the ophthalmologist were disrupting their life. Treatment expectations differed significantly between patients in terms of disease experience (visit and injection schedules), fears and feelings, and relationship with physicians, allowing three patient profiles to be identified: "Worried" patients (n = 45) felt isolated and were worried about the need for repeated treatment and possible side effects. They were mainly active men aged < 60 with type I diabetes (T1D) and DME diagnosed for > 2 years; "Curious" patients (n = 21) experienced insufficient support and requested more information on their disease and existing treatments. They were mainly single women aged 60-69 years; "Passive" patients (n = 50) felt sufficiently informed by their ophthalmologist and were not concerned by DME. They were older (mean age: 70 years) and mainly type 2 diabetic men. CONCLUSIONS: Patients with diabetes and macular edema treated with IVTI form a heterogeneous group regarding fears and expectations. Different patient profiles were identified and need to be confirmed in larger studies. A better understanding of psychological profiles may optimize compliance of diabetic patients.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/psicologia , Medo/fisiologia , Edema Macular/tratamento farmacológico , Edema Macular/psicologia , Motivação/fisiologia , Adulto , Idoso , Pré-Escolar , Estudos Transversais , Retinopatia Diabética/complicações , Retinopatia Diabética/epidemiologia , Medo/psicologia , Feminino , França/epidemiologia , Humanos , Injeções Intravítreas , Edema Macular/complicações , Edema Macular/epidemiologia , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente/psicologia , Cooperação do Paciente/estatística & dados numéricos , Preferência do Paciente/psicologia , Preferência do Paciente/estatística & dados numéricos , Inquéritos e Questionários , Acuidade Visual/efeitos dos fármacos
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