A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.
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
- 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
- •Diabetes mellitus 1 or 2, HbA1c < 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
- •Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
- •Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
- •Central foveal thickness >250µm (Optical Coherence Tomography).
- •Diabetes medication stable in the 3 months prior.
排除标准
- •In the study eye:
- •Active intraocular inflammation.
- •Any active infection.
- •History of uveitis.
- •Structural damage within 500 microns of the center of the macula.
- •Neovascularization of the iris.
- •Uncontrolled glaucoma in either eye (Intraocular Pressure > 24 mmHg).
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
RFB002
RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
干预措施: RFB002 (Drug)
Laser photocoagulation
At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
干预措施: Laser photocoagulation (Procedure)
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: Baseline, 12 months
Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.
次要结局
- Percentage of Participants With Improvement in BCVA(12 months)
- Evolution of Mean Change From Baseline in BCVA by Study Visit(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.(12 months)
- Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Percentage of CRT Change From Baseline by Study Visit(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)