Status:
ACTIVE_NOT_RECRUITING
An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Lead Sponsor:
Genentech, Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50-94 years
Brief Summary
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 tim...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05300724
Start Date
May 27 2022
End Date
June 30 2027
Last Update
December 30 2025
Active Locations (74)
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1
Retina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas, United States, 72764
2
The Retina Partners
Encino, California, United States, 91436-2018
3
Retina Consultants of Orange County
Fullerton, California, United States, 92835
4
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040