2022-500746-16-00招募中2 期
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
- 招募中
- 入组人数
- 107
- 试验地点
- 59
- 主要终点
- Change in square root GA lesion area in the study eye measured on fundus autofluorescence (FAF)
研究概览
简要总结
Change in GA lesion growth of eyes treated with JNJ-81201887 compared to sham control
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •60 years of age or older
- •Have non-subfoveal (defined as not involving the center point of the fovea) GA secondary to AMD with an area that can be measured and measures 2.5 mm2 to 17.5 mm2 (1- and 7- disc areas respectively), determined by the CRC from screening images of FAF and SD-OCT.
- •A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin) test for the sample collected at Screening and negative urine pregnancy test on Day 4 before receiving the study intervention.
- •Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in and able to complete all required assessments during the study. The ICF may be signed by an impartial witness and/or legally authorized representative depending on national/local regulations.
排除标准
- •History of or presence of retinal disease other than GA for example: diabetic retinopathy, macular edema, central serous chorioretinopathy, inherited retinal degeneration, toxic maculopathies (ie, hydroxychloroquine maculopathy), arterial and venous occlusive disease, macular hole that is present or has been previously repaired, or choroidal melanoma or other retinal diseases that in the opinion of the Investigator, could affect the safety of the participant or interpretation of test results during the course of the study.
- •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.
- •Presence of macular fibrosis or retinal epithelial tear, clinically relevant myopic degeneration, or vitreous hemorrhage a. Benign conditions of the vitreous (e.g, posterior vitreous detachment) or peripheral retina (e.g, paving stone degeneration, lattice degeneration, etc.) are permitted.
结局指标
主要结局
Change in square root GA lesion area in the study eye measured on fundus autofluorescence (FAF)
Change in square root GA lesion area in the study eye measured on fundus autofluorescence (FAF)
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (59)
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