Dexamethasone Posterior Segment Drug Delivery System Versus Laser Photocoagulation in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 284
- 试验地点
- 18
- 主要终点
- Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
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
- Single (Outcomes Assessor)
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
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Presence of macular edema
排除标准
- •Anticipated need for ocular surgery in the study eye during the study
- •Laser photocoagulation in the study eye within 3 months
- •Cataract surgery within 3 months
研究组 & 干预措施
Laser Photocoagulation
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
干预措施: Laser Photocoagulation (Procedure)
Dexamethasone
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
时间窗: Baseline to Month 12
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis.
次要结局
- Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye(Baseline to Month 12)
- Change From Baseline in Total Macular Leakage Area by FA in the Study Eye(Baseline to Month 12)
- Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye(Baseline to Month 12)