An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Study Details
Study Description
Brief Summary
This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). The main purpose 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 AMD stages. The anticipated duration of the study will be approximately 5.5 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intermediate AMD Participants with iAMD will be evaluated for the progression of iAMD to more advanced dry 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. |
Other: No intervention
No intervention will be administered in this study.
|
Outcome Measures
Primary Outcome Measures
- Rate of Conversion from iAMD to nGA /iRORA [Baseline up to 5.5 years]
- Rate of Conversion from nGA/iRORA to cRORA/GA [Baseline up to 5.5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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High-risk intermediate AMD with more than one large drusen >125 µm and AMD pigmentary abnormalities in study eye with no evidence of prior or active exudative macular neovascularization (MNV) in either eye
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nGA, iRORA, cRORA (on spectral domain optical coherence tomography [SD-OCT]), or GA secondary to AMD on color fundus photography (CFP) or fundus autofluorescence (FAF) in non-study eye
Exclusion Criteria:
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Macular disease in either eye with subretinal deposits not typical of AMD
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Pigmentary abnormalities of the retina in either eye not typical of AMD
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Atrophy in either eye due to causes other than AMD
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Any concurrent or history of ocular or intraocular condition in the study eye
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Intraocular surgery, including cataract surgery, within 3 months prior to Day 1
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Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
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Concurrent or history of laser photocoagulation or anti-VEGF treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
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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
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History of glaucoma-filtering surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment
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Uncontrolled progressive glaucoma
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Moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy in either eye
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History of recurrent infectious or inflammatory ocular disease in either eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Retina Partners | Encino | California | United States | 91436 |
| 2 | Bay Area Retina Associates | Walnut Creek | California | United States | 94598 |
| 3 | Florida Eye Associates | Melbourne | Florida | United States | 32901 |
| 4 | Austin Retina Associates | Austin | Texas | United States | 78705 |
| 5 | Austin Clinical Research LLC | Austin | Texas | United States | 78750 |
Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GE43220
- 2022-000046-15