An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Other: No intervention
- Registration Number
- NCT05300724
- Lead Sponsor
- Genentech, Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intermediate AMD No intervention Participants with iAMD will be evaluated for the progression of iAMD to more advanced atrophic 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.
- Primary Outcome Measures
Name Time Method Rate of Conversion from iAMD to nGA /iRORA Baseline up to 3 years Rate of Conversion from nGA/iRORA to cRORA/GA Baseline up to 3 years Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) Baseline up to 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Cleveland Clinic Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Retina Partners of Northwest Arkansas, PLLC
🇺🇸Springdale, Arkansas, United States
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
Ophthalmic Consultants of Long Island
🇺🇸Rockville Centre, New York, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States
Retina Vitreous Center
🇺🇸Edmond, Oklahoma, United States
EyeHealth Northwest
🇺🇸Portland, Oregon, United States
Casey Eye Institute - OHSU
🇺🇸Portland, Oregon, United States
Erie Retinal Surgery
🇺🇸Erie, Pennsylvania, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Retina Center, LLC
🇺🇸West Columbia, South Carolina, United States
Tennessee Retina PC
🇺🇸Nashville, Tennessee, United States
W Texas Retina Consultants PA
🇺🇸Abilene, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Retina Consultants of Texas
🇺🇸Bellaire, Texas, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Retina Specialists
🇺🇸DeSoto, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Rocky Mountain Retina
🇺🇸Salt Lake City, Utah, United States
Wagner Kapoor Institute
🇺🇸Norfolk, Virginia, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Marsden Eye Specialists
🇦🇺Parramatta, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
🇦🇺Sydney, New South Wales, Australia
Adelaide Eye and Retina Centre
🇦🇺Adelaide, South Australia, Australia
Centre For Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia
The Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
Centre Hospitalier Intercommunal
🇫🇷Creteil, France
Centre Ophtalmologique Pole Vision
🇫🇷Ecully, France
CHU de GRENOBLE
🇫🇷Grenoble, France
Hôpital de La Croix Rousse
🇫🇷Lyon, France
Centre Ophtalmologique Maison-Rouge
🇫🇷Strasbourg, France
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
University Medicine Gottingen Germany
🇩🇪Gottingen, Germany
Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie
🇩🇪Hannover, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitatsklinikum Munster
🇩🇪Münster, Germany
Augenzentrum am St Franziskus-Hospital
🇩🇪Münster, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Rambam Medical Center - PPDS
🇮🇱Haifa, Israel
Tel Aviv Sourasky Medical Center PPDS
🇮🇱Jerusalem, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico
🇮🇹Roma, Lazio, Italy
Ospedale S. Giuseppe Multimedica
🇮🇹Milano, Lombardia, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
🇮🇹Milano, Lombardia, Italy
Emanuelli Research and Development Center LLC
🇵🇷Arecibo, Puerto Rico