A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Ocugen
- 入组人数
- 237
- 试验地点
- 3
- 主要终点
- Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12
研究概览
简要总结
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm
详细描述
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to either of the following arms:
Treatment arm (OCU410) study subjects will receive single subretinal injection of 200 µL, OCU410 in the study eye with the optimal dose (N=158)
Control arm (untreated) (N=79)
A total of 237 subjects will be enrolled in the study. Subjects who are enrolled in the untreated control group of the study will not receive any treatment. Subjects randomized to the treatment arm may receive a single subretinal injection of OCU410 in the study eye, provided they meet all treatment eligibility criteria. Subjects who are randomized to the control arm will not receive any intervention during the initial 52 weeks (12 Months) of the study.
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 (Outcomes Assessor)
盲法说明
Assessor Masked
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 55 years of age or older at consent.
- •BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye.
- •Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas [DA], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety, and not contiguous with any areas of peripapillary atrophy.
- •Subjects with history of CNV diagnosis (inactive) in the fellow eye for ≥2 years prior to Screening; stable and treated CNV treatment prior to screening (stable and inactive); no active exudation at screening (confirmed by imaging at the discretion of the investigator)
- •Subjects who had prior treatment with an approved drug for AMD, e.g. Izervay® (avacincaptad pegol) or Syfovre® (pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye from screening visit. Subjects can receive an approved drug for AMD in the fellow eye, if required.
排除标准
- •Previous treatment with a gene-therapy or cell therapy product.
- •GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
- •Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.
- •Any history or current evidence of exudative ("wet") AMD in the study eye including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram. Subjects with active exudative CNV in the fellow eye will be exclude.
- •Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.
结局指标
主要结局
Rate of change (slope) of square root-transformed GA lesion area from baseline to Month 12
时间窗: Month 12
Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements
次要结局
- Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12(Month 12)
- Rate of change of ellipsoid zone (EZ) area loss at Month 12(Month 12)