Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Macular Function Using Multi-focal ERG
研究概览
简要总结
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
详细描述
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.
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
- 是
入选标准
- •Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
- •Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
- •Age 18 years or older
- •ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
- •Central foveal thickness >275 microns or presence of cystic edema on OCT studies.
- •For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
- •Ability to provide written informed consent • Capable of complying with study protocol
排除标准
- •History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
- •Intraocular injection of steroid medication within prior 4 months
- •Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
- •Previous laser photocoagulation within 4 months of study
- •Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
- •Patients who are pregnant.
- •Unwilling or unable to follow or comply with all study related procedures.
研究组 & 干预措施
Ozurdex PRN
0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
干预措施: Ozurdex (Drug)
Ozurdex Q16 weeks
0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
干预措施: Ozurdex (Drug)
结局指标
主要结局
Macular Function Using Multi-focal ERG
时间窗: baseline to 48 weeks
To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups
Macular Function Using Microperimetry
时间窗: baseline to 48 weeks
To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups
次要结局
- To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups(baseline to 48 weeks)
- To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups(baseline to 48 weeks)