Actively Recruiting // Age-related Macular Degeneration // Clinical Trials // Mihai Mititelu // Oct 07 2022
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
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.
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.
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
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