An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

Running, not enrolling

Conditions studied: Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT05300724

Run by

Genentech, Inc.

People needed

400

Starts

2022-05-27

Expected to finish

2027-06-30

Last updated by the study team

2026-06-17

Who can join

Age: 50 and older, up to 94. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• UC Davis Eye Center — Sacramento, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Southwest Retina Consultants — Durango, Colorado, United States
• Eye Care Center of Northern Colorado PC — Longmont, Colorado, United States
• Advanced Research — Coral Springs, Florida, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Raj K. Maturi, MD PC — Indianapolis, Indiana, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Cumberland Valley Retina Consultants PC — Hagerstown, Maryland, United States
• New England Retina Consultants — Springfield, Massachusetts, United States
• Foundation for Vision Research — Grand Rapids, Michigan, United States
• Deep Blue Retina Clinical Research — Southaven, Mississippi, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• Vitreous Retina Macula Consultants of New York — New York, New York, United States
• Retina Partners of Northwest Arkansas, PLLC — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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