A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 146
- 主要终点
- Rate of Conversion from iAMD to nGA /iRORA
研究概览
简要总结
This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (~144 weeks) for participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 94 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the study for at least 28 days after the last fluorescein injection for the fluorescein angiography (FA) administration
- •Study eye: High-risk intermediate AMD
排除标准
- •Macular disease in either eye with subretinal deposits not typical of AMD
- •Pigmentary abnormalities of the retina in either eye not typical of AMD
- •Atrophy in either eye due to causes other than AMD
- •Study eye: Any concurrent or history of ocular or intraocular condition
- •Study eye: Intraocular surgery, including cataract surgery, within 3 months prior to Day 1
- •Study eye: Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
- •Study eye: Concurrent or history of retinal laser photocoagulation or anti-vascular endothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
- •Study eye: Presence of choroidal nevus with overlying drusen in the circle with a radius 3600 micrometer centered on the fovea
- •Study eye: Previous participation in interventional clinical trials for GA or early stages of AMD, except for vitamins and minerals, regardless of the route of administration within the last 6 months, except for sham-arm participants
- •Study eye: History of glaucoma surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment
- •Either eye: Uncontrolled progressive glaucoma
- •Either eye: Moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
- •Either eye: History of recurrent infectious or inflammatory ocular disease
- •Any concurrent or history of taking medications that can induce retinal toxicity
研究组 & 干预措施
Intermediate AMD
Participants with iAMD will be evaluated for the progression of iAMD to more advanced atrophic AMD stages, such as nascent geographic atrophy (nGA) or incomplete retinal pigment epithelium and outer retinal atrophy (iRORA), and subsequently from nGA or iRORA to complete retinal pigment epithelium (cRORA) and outer retinal atrophy or geographic atrophy (GA), on Day 1 and thereafter every 12 weeks up to the end of the Observation Period, approximately 3 years.
干预措施: No intervention (Other)
结局指标
主要结局
Rate of Conversion from iAMD to nGA /iRORA
时间窗: Baseline up to 3 years
Rate of Conversion from nGA/iRORA to cRORA/GA
时间窗: Baseline up to 3 years
Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
时间窗: Baseline up to 3 years
次要结局
未报告次要终点