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Age-Related Macular DegenerationHONUNCT05300724

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

An observational study of Age-Related Macular Degeneration, run by Genentech, Inc. at 74 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 94 years
Conditions the study is for
Age-Related Macular Degeneration
How many people
400 participants
Where
74 sitesin 7 countries
Study dates
27 May 2022to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 94 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will enroll participants with high risk intermediate AMD.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

74 sites in 7 countries.

74 sites in 7 countries

United States46 sites

  • W Texas Retina Consultants PA

    Abilene, Texas, 79606

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Cleveland Clinic Cole Eye Institute

    Cleveland, Ohio, 44195

  • Advanced Research

    Coral Springs, Florida, 33067

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Retina Specialists

    DeSoto, Texas, 75115

  • Southwest Retina Consultants

    Durango, Colorado, 81303

  • Duke Eye Center

    Durham, North Carolina, 27705

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • The Retina Partners

    Encino, California, 91436-2018

  • Erie Retinal Surgery

    Erie, Pennsylvania, 16507

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana, 46290

  • Eye Care Center of Northern Colorado PC

    Longmont, Colorado, 80503

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53705-2275

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Vitreous Retina Macula Consultants of New York

    New York, New York, 10022

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • EyeHealth Northwest

    Portland, Oregon, 97224

  • Casey Eye Institute - OHSU

    Portland, Oregon, 97239

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York, 11570

  • UC Davis Eye Center

    Sacramento, California, 95817

  • Retinal Consultants Medical Group

    Sacramento, California, 95841-2013

  • Rocky Mountain Retina

    Salt Lake City, Utah, 84107

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi, 38671

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Partners of Northwest Arkansas, PLLC

    Springdale, Arkansas, 72764

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Palmetto Retina Center, LLC

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

Other trials in United States

Germany8 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • University Medicine Gottingen Germany

    Göttingen, 37075

  • Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie

    Hanover, 30625

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Universitatsklinikum Munster

    Münster, 48149

  • Augenzentrum am St Franziskus-Hospital

    Münster

  • Universitatsklinikum Tubingen

    Tübingen, 72076

Other trials in Germany

Australia5 sites

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Marsden Eye Specialists

    Parramatta, New South Wales, 2150

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

Other trials in Australia

France5 sites

  • Centre Hospitalier Intercommunal

    Créteil, 94010

  • Centre Ophtalmologique Pole Vision

    Écully, 69130

  • CHU de GRENOBLE

    Grenoble, 38043

  • Hôpital de La Croix Rousse

    Lyon, 69004

  • Centre Ophtalmologique Maison-Rouge

    Strasbourg, 67000

Other trials in France

Italy5 sites

  • Ospedale S. Giuseppe Multimedica

    Milan, Lombardy, 20123

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

    Milan, Lombardy, 20132

  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

    Milan, Lombardy, 20157

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

    Rome, Lazio

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

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Israel4 sites

  • Rambam Medical Center - PPDS

    Haifa, 3109600

  • Tel Aviv Sourasky Medical Center PPDS

    Jerusalem, 90000

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
No intervention
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention will be administered in this study.

Study groups in NCT05300724
Study groupRoleWhat they receive
Intermediate AMDParticipants 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.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Conversion from iAMD to nGA /iRORA

    Measured: Baseline up to 3 years

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

    Measured: Baseline up to 3 years

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

    Measured: Baseline up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start27 May 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05300724
Sponsor's protocol ID
GE43220
Other IDs
2022-000046-15
Acronym
HONU
Status last verified
Sep 2026
First submitted
18 Mar 2022
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration, run by Genentech, Inc. at 74 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Germany, Australia, France, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Conversion from iAMD to nGA /iRORA (time frame: Baseline up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05300724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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