A 12-month, Two-armed, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Laser Photocoagulation as Adjunctive to Ranibizumab Intravitreal Injections vs. Laser Photocoagulation Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema Followed by a 12 Month Follow up Period
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
研究概览
简要总结
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
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
- Double (Participant, Investigator)
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
- •Visual acuity impairment caused by macular edema in at least one eye
- •Type 1 or type 2 diabetes mellitus
- •Stable medication of diabetes in past 3 month
排除标准
- •Patients with uncontrolled systemic or ocular diseases
- •Laser photocoagulation in the study eye for the last 3 months
- •Any history of any intraocular surgery in the study eye within the past 3 months
- •Blood pressure > 160/100 mmHg
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Active laser photocoagulation and ranibizumab
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
干预措施: Active laser photocoagulation (Procedure)
Active laser photocoagulation and ranibizumab
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
干预措施: Ranibizumab 0.5 mg (Drug)
Active laser photocoagulation and sham injection
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
干预措施: Active laser photocoagulation (Procedure)
Active laser photocoagulation and sham injection
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
干预措施: Sham injections (Drug)
结局指标
主要结局
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
时间窗: 12 months
Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
次要结局
未报告次要终点