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

June 16, 2026 updated by: Genentech, Inc.

A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 94 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will enroll participants with high risk intermediate AMD.

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
No intervention will be administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Conversion from iAMD to nGA /iRORA
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Rate of Conversion from nGA/iRORA to cRORA/GA
Time Frame: Baseline up to 3 years
Baseline up to 3 years
Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time Frame: Baseline up to 3 years
Baseline up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE43220
  • 2022-000046-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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