A 24 Month Open-label, Multicenter, Phase IIIb Study of the Efficacy and Safety of Lucentis® (Ranibizumab 0,5mg) in Diabetic Patients With Visual Impairment Due to Macular Edema Evaluating a Spaced Out Follow-up After Intensive Loading Phase
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months
研究概览
简要总结
The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.
详细描述
This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.
Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 [Day 0]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.
The trial was terminated before any patient reached month 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I or type II diabetes with HbA1c≤10%
- •Visual impairment due to a diabetic macular edema
- •Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary
排除标准
- •Inflammation or infection in one eye
- •Women of childbearing potential without an efficient contraception, pregnant or breastfeeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ranibizumab 0.5mg
Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
干预措施: Ranibizumab 0.5mg (Drug)
结局指标
主要结局
Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months
时间窗: Month 6 and 24
Best-Corrected Visual Acuity (BCVA) letters were measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) were reported.
次要结局
- Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 Letters(Baseline, Month 3, 6, 8 and 11)
- Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 Letters(Baseline, Months 3, 6, 8 and 11)
- Evaluation of the Spaced Out Follow-up on Visual Functions and Quality of Life(baseline, months 11, 12 and 24)
- Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye - Rescue Group(Baseline, Months 3, 6, 8 and 11)
- Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 11 Months(Month 11 and 24)
- Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS)(Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11)
- Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye(Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11)
- Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye.(Months 6, 8 and 11)
- Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) - Rescue Group(Baseline, Months 3, 6, 8 and 11)