Sirolimus Versus AntiVEGF for Wet AMD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography
研究概览
简要总结
Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.
详细描述
Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)
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 (Participant)
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
- •best corrected visual acuity of 5-65, inclusive, in study eye
- •presence of choroid neovascularization secondary to AMD
- •persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months
排除标准
- •greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit
- •history of major ophthalmic surgery in the study eye in the past 3 months
- •history of significant ocular disease or condition other than exudative AMD that may confound results
研究组 & 干预措施
Sirolimus
Intravitreal Sirolimus
干预措施: Sirolimus (Drug)
Standard of Care intravitreal anti-VEGF
anti-VEGF intravitreal injections
干预措施: Standard of Care intravitreal injections of anti-VEGF (Drug)
结局指标
主要结局
Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography
时间窗: Baseline to 6 months
Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group
Visual Acuity
时间窗: Baseline to 6 months
number of subjects with gain of 0-4 letters of visual acuity
次要结局
- Visual Acuity (Best Corrected Visual Acuity)(baseline to 6 months)