NCT00083967终止2 期
A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Rhegmatogenous Retinal Detachment
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 60
- 主要终点
- Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects
研究概览
简要总结
The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.
详细描述
The purpose of this trial is to determine if administration of denufosol is well-tolerated and more efficacious than placebo in stimulating subretinal fluid reabsorption and retinal reattachment without surgical intervention in subjects presenting with rhegmatogenous retinal detachment.
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
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
- •have rhegmatogenous retinal detachment in only one eye
- •be able to receive intravitreal injection of study drug and be able to wait 24(+/- 6) hours to have detachment surgically treated or retinal breaks repaired per judgement of investigator
- •no more than 3 separate identifiable retinal breaks that are clustered together and confined within an area no more than 2 clock hours in extent
- •retinal detachment must be large enough such that it cannot be immediately repaired with laser photocoagulation or cryotherapy
- •have pinhole acuity (using ETDRS) of macula-on, 20/50 or better in both eyes OR macula-off, 20/50 or better in non-study eye and have history, prior to detachment, of reading capability in study eye
排除标准
- •have a non-rhegmatogenous retinal detachment
- •have large retinal break(s) whose total break area is greater than 1 clock hour in extent
- •have evidence of atrophic retinal pigment epithelium, choroid, choroidal detachment or intraocular inflammation
- •be monocular
- •have a prior retinal detachment repair or a congenital condition that places a greater risk for rhegmatogenous retinal detachment
- •have proliferative vitreoretinopathy greater than grade B
- •have pre-existing subretinal or vitreous hemorrhage, corneal opacity, or other conditions which limit the view of peripheral retina
- •have any co-existing macular pathology or other retinal conditions that can limit visual acuity
- •currently have uncontrollable elevated intraocular pressure, advanced glaucoma, or any history or current evidence of endophthalmitis in the affected eye
- •have symptoms consistent with a rhegmatogenous retinal detachment such as visual disturbance greater than 14 days prior to screening if macula-on OR history of loss of reading vision in affected eye for greater than 6 days prior to screening if macula-off
- •have a retinal detachment with evidence of demarcation lines or evidence of subretinal fibrosis visible upon fundus examination
- •be currently taking medications that could obscure or confound study results including acetazolamide (Diamox) and dorzolamide
- •have had a periocular, retrobulbar or intravitreal injection in the affected eye, including corticosteroids in the 3 months prior to screening or require one
结局指标
主要结局
Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects
Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
次要结局
- Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3
- Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment
研究者
研究点 (60)
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