An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
NCT ID: NCT05300724
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
400 participants
OBSERVATIONAL
2022-05-27
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Intermediate AMD
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.
No intervention
No intervention will be administered in this study.
Interventions
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No intervention
No intervention will be administered in this study.
Eligibility Criteria
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Inclusion Criteria
* Study eye: High-risk intermediate AMD
Exclusion Criteria
* 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
50 Years
94 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, 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
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
Créteil, , France
Centre Ophtalmologique Pole Vision
Écully, , France
CHU de GRENOBLE
Grenoble, , France
Hôpital de La Croix Rousse
Lyon, , France
Centre Ophtalmologique Maison-Rouge
Strasbourg, , France
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
University Medicine Gottingen Germany
Göttingen, , Germany
Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie
Hanover, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Universitatsklinikum Munster
Münster, , Germany
Augenzentrum am St Franziskus-Hospital
Münster, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
Rambam Medical Center - PPDS
Haifa, , Israel
Tel Aviv Sourasky Medical Center PPDS
Jerusalem, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy
Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy
Ospedale S. Giuseppe Multimedica
Milan, Lombardy, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Lombardy, Italy
Emanuelli Research and Development Center LLC
Arecibo, , Puerto Rico
Countries
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Other Identifiers
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2022-000046-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GE43220
Identifier Type: -
Identifier Source: org_study_id