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) - 81201887MDG2001

Janssen - Cilag International0 个研究点目标入组 274 人开始时间: 2023年3月2日最近更新: 2024年8月21日

适应症

试验速览

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•1. 60 years of age or older, 2. 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., 3. A woman of childbearing potential must have a negative highly sensitive serum (ß-human chorionic gonadotropin) test for the sample collected at Screening and negative urine pregnancy test on Day 4 before receiving the study intervention., 4. 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.

•1. 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., 3. History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye., 4. Any prior thermal laser in the macular region, regardless of indication., 2. 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.

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