French Evaluation Group Avastin Versus Lucentis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Evaluation of the mean change from inclusion to 12 months post initiation of treatment in VA score, measured on the "Early Treatment Diabetic Retinopathy Study" (ETDRS) scale at an initial distance of 4 meters.
研究概览
简要总结
Age Related Macular Degeneration (AMD) is the first cause of visual impairment in elderly patients in industrialized countries. Neovascular or "wet" AMD, characterized by the presence of choroïdal neovessels, represents the most aggressive form of the disease. Its prevalence is 3.3% among patients older than 65 years in Europe, and increases with age.
Intraocular injections of anti-angiogenic monoclonal antibodies (ranibizumab) to treat AMD have appeared recently. It is derived from a larger sized molecule, bevacizumab, which do not have the market authorization for this indication. However, numerous publications of case series seem to show the effectiveness and a satisfactory safety profile of bevacizumab.
These conclusions have to be confirmed with a high level of evidence study. The aim of the GEFAL study is to demonstrate non-inferiority of effectiveness in clinical terms after 12 months of treatment with bevacizumab compared to ranibizumab on the visual acuity of patients affected by neovascular AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years old
- •Affected by neovascular retrofoveal AMD whatever the subtype, unilateral or bilateral (the eye included will be chosen by the investigator and the patient);
- •Best corrected VA for the studied eye ranging between 20/32 (6.3/10) and 20/320 (0.6/10) with ETDRS scale
- •Size of lesion < 12 disk area
- •In case of occult neovessels, proof required of recent development of the lesion: loss of VA of at least 5 letters ETDRS (equivalent one line) in the last 3 months OR appearance of a subretinal heamorrhage OR increase in the size of the lesion (> 10%) using fluoresceinic angiography during the last month by comparison with the last 3 months OR appearance of OCT criteria of macular oedema type, serous separation of neuro-epithelium, separation of the pigmented epithelial during the last month
- •Effective birth control for sexually active female
- •Signed informed consent.
排除标准
- •Previous or actual treatment with intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab or pegaptanib) in the studied eye
- •Other healing treatment in the studied eye during the last 3 months before the first injection
- •Medical history of photocoagulation in the studied eye
- •Involvement in another clinical study (studied eye and/or the other eye)
- •Subretinal haemorrhage reaching the fovea centre, with a size > 50% of the lesion area
- •Fibrosis or retrofoveal retinal atrophy in the studied eye
- •Retinal pigment epithelial tear reaching the macula in the studied eye
- •Choroidal neovascularisation not related to a DMLA in the studied eye
- •Medical history of intravitreal medical device in the studied eye
- •Active or suspected ocular or peri-ocular infection
- •Serious active intra-ocular inflammation in the studied eye
- •Medical history of auto-immune or idiopathic uveitis
- •Proved diabetic retinopathy
- •Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
- •Medical history of intra-ocular surgery within 2 months before the first injection in the studied eye
- •Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
- •Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
- •Known hypersensitivity to ranibizumab, bevacizumab, or another drug composite of the medicinal products used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
- •Arterial hypertension that is not controlled by an appropriate treatment
- •Previous or actual treatment with systemic administration of bevacizumab
- •Follow up not possible during 12 months
- •No affiliation to the French national health insurance program.
研究组 & 干预措施
Avastin
intravitreal injection of bevacizumab
干预措施: Avastin (Drug)
Lucentis
intravitreal injection of ranibizumab
干预措施: Lucentis (Drug)
结局指标
主要结局
Evaluation of the mean change from inclusion to 12 months post initiation of treatment in VA score, measured on the "Early Treatment Diabetic Retinopathy Study" (ETDRS) scale at an initial distance of 4 meters.
时间窗: 12 months
次要结局
- Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab(12 months)
- Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups.(12 months)
- Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups(12 months)
- Describe the pharmacokinetic profile of the drugs in blood and aqueous humor in a sub-group of 20 patients, during the induction stage.(3 months)
- Create a medico-economic model of the impact related to the two strategies.(12 months)