A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration (iAMD)
- Sponsor: Genentech, Inc.
- Principal Investigator: Mihai Mititelu, MD, MPH
- Study Coordinator: Angie Adler
Study objective:
The 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.
Study design:
Structural changes in imaging characteristics on multimodal imaging instruments and their relationship with visual function parameters will be followed over approximately 3 years. This is an observational natural history trial and therefore no specific drug therapy will be evaluated.
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
- 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
- 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:
- 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
- Intraocular surgery, including cataract surgery, within 3 months prior to Day 1
- Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
- Concurrent or history of laser photocoagulation or anti-VEGF treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
- 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
- History of glaucoma-filtering surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment
- Uncontrolled progressive glaucoma
- Moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy in either eye
- History of recurrent infectious or inflammatory ocular disease in either eye
Contact Angie Adler with questions: 608-265-7557.
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