Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 262
- 主要终点
- Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
研究概览
简要总结
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
排除标准
- •History of glaucoma, ocular hypertension or optic nerve head change
- •Any active bacterial, viral, parasitic, or fungal infections in either eye
- •Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
- •History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
- •Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
- •Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
- •Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
研究组 & 干预措施
700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
干预措施: 700 μg Dexamethasone (Drug)
Sham
Sham administered in the study eye on Day 1.
干预措施: 700 μg Dexamethasone (Drug)
Sham
Sham administered in the study eye on Day 1.
干预措施: Sham (Other)
结局指标
主要结局
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
时间窗: Baseline, 6 Months
BCVA is measured 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 means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
次要结局
- Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Change From Baseline in BCVA in the Study Eye(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Average Change From Baseline in BCVA in the Study Eye(Baseline, 6 Months)