CTRI/2018/05/014065已完成3 期
Prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety ofR-TPR-024 / Lucentis® in patients with neovascular (wet) age-related macular degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 16
- 主要终点
- proportion of patients who lost fewer than 15 letters in visual acuity
研究概览
简要总结
This prospective, multi-centre, double-blind, two-arm, parallel group, activecontrol, randomized comparative clinical trial is being conducted to compare the efficacy and safety of R-TPR-024 vs. Lucentis® in patients with neovascular(wet) age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients of age ≥ 50 years.
- •2.Active primary or recurrent subfoveal lesions with classic or occult choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
- •3.Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.
排除标准
- •1.Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the nonstudy eye within 1 week prior to randomization.
- •2.Previous external-beam radiation therapy, transpupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye.
- •3.Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to randomization.
- •4.CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
- •5.Patients with controlled or uncontrolled diabetes mellitus.
结局指标
主要结局
proportion of patients who lost fewer than 15 letters in visual acuity
时间窗: proportion of patients who lost fewer than 15 letters in visual acuity
次要结局
- immunogenicity, safety and tolerability of R-TPR-024 / Lucentis®(at week 24 from Baseline)
研究者
研究点 (16)
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