CClinicalTrials.gg
Active, not recruitingNCT05300724HONUUpdated Sep 16, 2026

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

An observational study in Age-Related Macular Degeneration, sponsored by Genentech, Inc.. Active, not recruiting at 74 sites in 7 countries. Open to participants aged 50 Years to 94 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Genentech, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
400
Ages
50 Years to 94 Years
Sex
All
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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.

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Conditions studied

  • Age-Related Macular Degeneration
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 400 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 94 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will enroll participants with high risk intermediate AMD.

Inclusion criteria

  • 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

Exclusion criteria

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 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo intervention

    No intervention will be administered in this study.

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What researchers measure

Primary outcomes

  1. Rate of Conversion from iAMD to nGA /iRORA

    Time frame: Baseline up to 3 years

  2. Rate of Conversion from nGA/iRORA to cRORA/GA

    Time frame: Baseline up to 3 years

  3. Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

    Time frame: Baseline up to 3 years

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Study locations

74 sites
  • Retina Partners of Northwest Arkansas, PLLC
    Springdale, Arkansas 72764, United States
  • The Retina Partners
    Encino, California 91436-2018, United States
  • Retina Consultants of Orange County
    Fullerton, California 92835, United States
  • Northern California Retina Vitreous Associates
    Mountain View, California 94040, United States
  • Retina Consultants, San Diego
    Poway, California 92064, United States
  • UC Davis Eye Center
    Sacramento, California 95817, United States
  • Retinal Consultants Medical Group
    Sacramento, California 95841-2013, United States
  • Bay Area Retina Associates
    Walnut Creek, California 94598, United States
  • Southwest Retina Consultants
    Durango, Colorado 81303, United States
  • Eye Care Center of Northern Colorado PC
    Longmont, Colorado 80503, United States
  • Advanced Research
    Coral Springs, Florida 33067, United States
  • Rand Eye Institute
    Deerfield Beach, Florida 33064, United States
  • National Ophthalmic Research Institute
    Fort Myers, Florida 33912, United States
  • Florida Eye Associates
    Melbourne, Florida 32901, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
  • University Retina and Macula Associates, PC
    Oak Forest, Illinois 60452, United States
  • Raj K. Maturi, MD PC
    Indianapolis, Indiana 46290, United States
  • Wolfe Eye Clinic
    West Des Moines, Iowa 50266, United States
  • Cumberland Valley Retina Consultants PC
    Hagerstown, Maryland 21740, United States
  • New England Retina Consultants
    Springfield, Massachusetts 01107, United States
  • Foundation for Vision Research
    Grand Rapids, Michigan 49546, United States
  • Deep Blue Retina Clinical Research
    Southaven, Mississippi 38671, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • Eye Associates of New Mexico
    Albuquerque, New Mexico 87109, United States
  • Vitreous Retina Macula Consultants of New York
    New York, New York 10022, United States
  • Ophthalmic Consultants of Long Island
    Rockville Centre, New York 11570, United States
  • Duke Eye Center
    Durham, North Carolina 27705, United States
  • Cleveland Clinic Cole Eye Institute
    Cleveland, Ohio 44195, United States
  • Retina Vitreous Center
    Edmond, Oklahoma 73013, United States
  • EyeHealth Northwest
    Portland, Oregon 97224, United States
  • Casey Eye Institute - OHSU
    Portland, Oregon 97239, United States
  • Erie Retinal Surgery
    Erie, Pennsylvania 16507, United States
  • Scheie Eye Institute
    Philadelphia, Pennsylvania 19104, United States
  • Palmetto Retina Center, LLC
    West Columbia, South Carolina 29169, United States
  • Tennessee Retina PC
    Nashville, Tennessee 37203, United States
  • W Texas Retina Consultants PA
    Abilene, Texas 79606, United States
  • Austin Retina Associates
    Austin, Texas 78705, United States
  • Austin Clinical Research LLC
    Austin, Texas 78750, United States
  • Retina Consultants of Texas
    Bellaire, Texas 77401, United States
  • Retina Foundation of the Southwest
    Dallas, Texas 75231, United States
  • Retina Specialists
    DeSoto, Texas 75115, United States
  • San Antonio Eye Center
    San Antonio, Texas 78215, United States
  • Rocky Mountain Retina
    Salt Lake City, Utah 84107, United States
  • Wagner Kapoor Institute
    Norfolk, Virginia 23502, United States
  • Spokane Eye Clinical Research
    Spokane, Washington 99204, United States
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53705-2275, United States
  • Marsden Eye Specialists
    Parramatta, New South Wales 2150, Australia
  • Sydney Retina Clinic and Day Surgery
    Sydney, New South Wales 2000, Australia
  • Adelaide Eye and Retina Centre
    Adelaide, South Australia 5000, Australia
  • Centre For Eye Research Australia
    East Melbourne, Victoria 3002, Australia
  • The Lions Eye Institute
    Nedlands, Western Australia 6009, Australia
  • Centre Hospitalier Intercommunal
    Créteil, 94010, France
  • Centre Ophtalmologique Pole Vision
    Écully, 69130, France
  • CHU de GRENOBLE
    Grenoble, 38043, France
  • Hôpital de La Croix Rousse
    Lyon, 69004, France
  • Centre Ophtalmologique Maison-Rouge
    Strasbourg, 67000, France
  • Universitätsklinikum Bonn
    Bonn, 53127, Germany
  • Universitätsklinikum Freiburg
    Freiburg im Breisgau, 79106, Germany
  • University Medicine Gottingen Germany
    Göttingen, 37075, Germany
  • Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie
    Hanover, 30625, Germany
  • Universitatsklinikum Leipzig
    Leipzig, 04103, Germany
  • Universitatsklinikum Munster
    Münster, 48149, Germany
  • Augenzentrum am St Franziskus-Hospital
    Münster, Germany
  • Universitatsklinikum Tubingen
    Tübingen, 72076, Germany
  • Rambam Medical Center - PPDS
    Haifa, 3109600, Israel
  • Tel Aviv Sourasky Medical Center PPDS
    Jerusalem, 90000, Israel
  • Hadassah Medical Center
    Jerusalem, 91120, Israel
  • Rabin Medical Center
    Petah Tikva, 49100, Israel
  • Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
    Udine, Friuli Venezia Giulia 33100, 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 20123, Italy
  • Ospedale San Raffaele S.r.l. - PPDS
    Milan, Lombardy 20132, Italy
  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
    Milan, Lombardy 20157, Italy
  • Emanuelli Research and Development Center LLC
    Arecibo, 00612, Puerto Rico
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05300724
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Mar 29, 2022
Start date
May 27, 2022
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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