A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 300
- 主要终点
- Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
研究概览
简要总结
The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT)
- •If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5- disc area), as assessed by the CRC
- •GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC
- •Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better
- •Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)
排除标准
- •History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
- •Any prior thermal laser in the macular region, regardless of indication
- •History of retinal detachment (with or without repair)
- •Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- •Any sign of diabetic retinopathy or central serous chorioretinopathy
研究组 & 干预措施
Arm A: JNJ-81201887 Low Dose
Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
干预措施: JNJ-81201887 (Drug)
Arm A: JNJ-81201887 Low Dose
Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
干预措施: Prednisone (Drug)
Arm A: JNJ-81201887 Low Dose
Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
干预措施: Triamcinolone (Drug)
Arm B: JNJ-81201887 High dose
Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
干预措施: JNJ-81201887 (Drug)
Arm B: JNJ-81201887 High dose
Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
干预措施: Prednisone (Drug)
Arm B: JNJ-81201887 High dose
Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
干预措施: Triamcinolone (Drug)
Arm C: Sham Procedure
Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular triamcinolone (corticosteroid injection) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
干预措施: Placebo (Other)
Arm C: Sham Procedure
Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular triamcinolone (corticosteroid injection) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
干预措施: Sham Procedure (Other)
结局指标
主要结局
Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
时间窗: Baseline and Month 18
Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye
时间窗: Baseline to Month 18
Rate of Change in untransformed GA lesion area in the study eye will be measured via retinal imaging using FAF. A piecewise linear mixed effects (PLME) model will be used for the primary efficacy analysis for rate of change in GA area (GAA) in the study eye.
次要结局
- Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18(Baseline and Month 18)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18(Baseline and Month 18)
- Change From Baseline in Reading Speed at Month 18(Baseline and Month 18)
- Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18(Baseline and Month 18)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18(Baseline and Month 18)
- Change From Baseline in Functional Reading Independence (FRI) Index at Month 18(Baseline and Month 18)