Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 253
- 主要终点
- Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with 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
- Triple (Participant, Care Provider, 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
- •18 years of age or older with diabetic macular edema
- •Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- •Visual acuity in other eye no worse than 20/200
排除标准
- •Known anticipated need for ocular surgery within next 12 months
- •History of glaucoma or current high eye pressure requiring more than 1 medication
- •Uncontrolled systemic disease
- •Known steroid-responder
- •Use of systemic steroids - Use of Warfarin/Heparin
研究组 & 干预措施
700 µg Dexamethasone Implant and Laser Photocoagulation
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
干预措施: Dexamethasone (Drug)
700 µg Dexamethasone Implant and Laser Photocoagulation
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
干预措施: Laser Photocoagulation (Procedure)
Sham Implant and Laser Photocoagulation
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
干预措施: Sham injection (Drug)
Sham Implant and Laser Photocoagulation
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
干预措施: Laser Photocoagulation (Procedure)
结局指标
主要结局
Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye
时间窗: Baseline, Month 12
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
次要结局
- Change From Baseline in the Focal Leakage Area in the Study Eye(Baseline, Month 12)
- Change From Baseline in Central Subfield Retinal Thickness in the Study Eye(Baseline, Month 12)
- Time to Retreatment in the Study Eye(12 Months)
- Change From Baseline in BCVA in the Study Eye(Baseline, Month 12)