An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

Last updated: April 7, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aging

Macular Degeneration

Geographic Atrophy

Treatment

No intervention

Clinical Study ID

NCT05300724
GE43220
2022-000046-15
  • Ages 50-94
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For women of childbearing potential, agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraception, during the study for at least 28days after the last fluorescein injection for the fluorescein angiography (FA)administration

  • Study eye: High-risk intermediate AMD

Exclusion

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

  • Study eye: Any concurrent or history of ocular or intraocular condition

  • Study eye: Intraocular surgery, including cataract surgery, within 3 months prior toDay 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-vascularendothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macularedema, retinal vein occlusion, or proliferative diabetic retinopathy

  • Study eye: Presence of choroidal nevus with overlying drusen in the circle with aradius 3600 micrometer centered on the fovea

  • Study eye: Previous participation in interventional clinical trials for GA or earlystages of AMD, except for vitamins and minerals, regardless of the route ofadministration within the last 6 months, except for sham-arm participants

  • Study eye: History of glaucoma surgery, corneal transplant, retinal pigmentepithelium tear, retinal tear that involves the macula, retinal detachment

  • Either eye: Uncontrolled progressive glaucoma

  • Either eye: Moderate or severe non-proliferative diabetic retinopathy orproliferative 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

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
May 27, 2022
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Marsden Eye Specialists

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Sydney Eye Hospital

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Centre For Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • The Lions Eye Institute

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Centre Hospitalier Intercommunal

    Creteil, 94010
    France

    Site Not Available

  • Centre Ophtalmologique Pole Vision

    Ecully, 69130
    France

    Site Not Available

  • CHU de GRENOBLE

    Grenoble, 38043
    France

    Site Not Available

  • Centre ophtalmologique Rabelais; Ophtalmologie

    Lyon, 69003
    France

    Site Not Available

  • Hôpital de La Croix Rousse

    Lyon, 69004
    France

    Site Not Available

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010
    France

    Site Not Available

  • Hospital Foundation Adolphe De Rothschild

    Paris, 75019
    France

    Site Not Available

  • Centre Ophtalmologique Maison-Rouge

    Strasbourg, 67000
    France

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Bonn; Medizinische Klinik II, Zentrum für Integrative Medizin (ZIM)

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • University Medicine Gottingen Germany

    Gottingen, 37075
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie

    Hannover, 30625
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Augenzentrum am St Franziskus-Hospital

    Münster,
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Rambam Medical Center - PPDS

    Haifa, 3109600
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Jerusalem, 90000
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Rabin Medical Center; Liver Inst.

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv-Yafo, 6423906
    Israel

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia

    Udine, Friuli-Venezia Giulia 33100
    Italy

    Site Not Available

  • Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico

    Roma, Lazio
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

    Milano, Lombardia 20157
    Italy

    Site Not Available

  • Ospedale S. Giuseppe Multimedica

    Milano, Lombardia 20123
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l. - PPDS

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Retina Partners of Northwest Arkansas, PLLC

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • The Retina Partners

    Encino, California 91436
    United States

    Site Not Available

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates

    Mountain View, California 94040
    United States

    Site Not Available

  • Retina Consultants, San Diego

    Poway, California 92064
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento, California 95841-2013
    United States

    Site Not Available

  • UC Davis Eye Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Southwest Retina Consultants

    Durango, Colorado 81303
    United States

    Site Not Available

  • Eye Care Center of Northern Colorado PC

    Longmont, Colorado 80503
    United States

    Site Not Available

  • Advanced Research

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Advanced Research

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Florida Eye Associates

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Illinois Eye and Ear Infirmary

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Wolfe Eye Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • New England Retina Consultants

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Foundation for Vision Research

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Retina Specialists of Michigan

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Site Not Available

  • Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Ross Eye Institute

    Buffalo, New York 14209-2102
    United States

    Site Not Available

  • Vitreous Retina Macula Consultants of New York

    New York, New York 10022
    United States

    Site Not Available

  • Ophthalmic Consultants of Long Island

    Oceanside, New York 11572
    United States

    Site Not Available

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Duke Eye Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cleveland Clinic Cole Eye Institute

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Retina Vitreous Center

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Casey Eye Institute - OHSU

    Portland, Oregon 97239
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97224
    United States

    Site Not Available

  • Erie Retinal Surgery

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Eye Care Specialists, PC

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Charleston Neuroscience Institute

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Palmetto Retina Center, LLC

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Tennessee Retina PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt Vision Research Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • W Texas Retina Consultants PA

    Abilene, Texas 79606
    United States

    Site Not Available

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina Foundation of the Southwest

    Dallas, Texas 75231
    United States

    Site Not Available

  • Retina Specialists

    DeSoto, Texas 75115
    United States

    Site Not Available

  • San Antonio Eye Center

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 77384-4167
    United States

    Site Not Available

  • Utah Eye Center

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Rocky Mountain Retina

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Wagner Kapoor Institute

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Wagner Macula & Retina Center

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

  • West Virginia University Eye Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53705-2275
    United States

    Site Not Available

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