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

NCT05300724 | Active Not Recruiting

• 2 other identifiers: GE432202022-000046-15
• Study Type: observational
• Target: 400
• Locations: 7 countries
• Sites: 74

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention will be administered in this study.

Intermediate AMD

Eligibility Criteria

• Age: 50 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll participants with high risk intermediate AMD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (74)

Retina Partners of Northwest Arkansas, PLLC

Springdale, Arkansas, 72764, United States

Location

The Retina Partners

Encino, California, 91436-2018, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retina Consultants, San Diego

Poway, California, 92064, United States

Location

UC Davis Eye Center

Sacramento, California, 95817, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95841-2013, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Southwest Retina Consultants

Durango, Colorado, 81303, United States

Location

Eye Care Center of Northern Colorado PC

Longmont, Colorado, 80503, United States

Location

Advanced Research

Coral Springs, Florida, 33067, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Raj K. Maturi, MD PC

Indianapolis, Indiana, 46290, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, United States

Location

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49546, United States

Location

Deep Blue Retina Clinical Research

Southaven, Mississippi, 38671, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Retina Vitreous Center

Edmond, Oklahoma, 73013, United States

Location

EyeHealth Northwest

Portland, Oregon, 97224, United States

Location

Casey Eye Institute - OHSU

Portland, Oregon, 97239, United States

Location

Erie Retinal Surgery

Erie, Pennsylvania, 16507, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Palmetto Retina Center, LLC

West Columbia, South Carolina, 29169, United States

Location

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

Location

W Texas Retina Consultants PA

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Retina Specialists

DeSoto, Texas, 75115, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78215, United States

Location

Rocky Mountain Retina

Salt Lake City, Utah, 84107, United States

Location

Wagner Kapoor Institute

Norfolk, Virginia, 23502, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705-2275, United States

Location

Marsden Eye Specialists

Parramatta, New South Wales, 2150, Australia

Location

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Centre For Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

Centre Hospitalier Intercommunal

Créteil, 94010, France

Location

Centre Ophtalmologique Pole Vision

Écully, 69130, France

Location

CHU de GRENOBLE

Grenoble, 38043, France

Location

Hôpital de La Croix Rousse

Lyon, 69004, France

Location

Centre Ophtalmologique Maison-Rouge

Strasbourg, 67000, France

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Medicine Gottingen Germany

Göttingen, 37075, Germany

Location

Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie

Hanover, 30625, Germany

Location

Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Augenzentrum am St Franziskus-Hospital

Münster, Germany

Location

Universitatsklinikum Tubingen

Tübingen, 72076, Germany

Location

Rambam Medical Center - PPDS

Haifa, 3109600, Israel

Location

Tel Aviv Sourasky Medical Center PPDS

Jerusalem, 90000, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

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

Udine, Friuli Venezia Giulia, 33100, Italy

Location

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

Rome, Lazio, Italy

Location

Ospedale S. Giuseppe Multimedica

Milan, Lombardy, 20123, Italy

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20132, Italy

Location

ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

Milan, Lombardy, 20157, Italy

Location

Emanuelli Research and Development Center LLC

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: May 27, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); DE (8); IL (4); IT (5); AU (5); PR (1); US (46)