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

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: Recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: GE43220 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • New South Wales
    • Parramatta, New South Wales, Australia, 2150
      • Recruiting
      • Marsden Eye Specialists
    • Sydney, New South Wales, Australia, 2000
      • Recruiting
      • Sydney Retina Clinic and Day Surgery
    • Sydney, New South Wales, Australia, 2000
      • Withdrawn
      • Sydney Eye Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Adelaide Eye and Retina Centre
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Centre for Eye Research Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • The Lions Eye Institute
• France
  • Creteil, France, 94010
    • Recruiting
    • Centre Hospitalier Intercommunal
  • Ecully, France, 69130
    • Recruiting
    • Centre Ophtalmologique Pole Vision
  • Grenoble, France, 38043
    • Recruiting
    • CHU de Grenoble
  • Lyon, France, 69004
    • Recruiting
    • Hopital de la Croix Rousse
  • Lyon, France, 69003
    • Completed
    • Centre ophtalmologique Rabelais; Ophtalmologie
  • Paris, France, 75010
    • Recruiting
    • Hopital Lariboisiere; Ophtalmologie
  • Paris, France, 75019
    • Recruiting
    • Hospital Foundation Adolphe De Rothschild
  • Strasbourg, France, 67000
    • Recruiting
    • Centre Ophtalmologique Maison-Rouge
• Germany
  • Bonn, Germany, 53127
    • Recruiting
    • Universitätsklinikum Bonn; Medizinische Klinik II, Zentrum für Integrative Medizin (ZIM)
  • Freiburg, Germany, 79106
    • Recruiting
    • Universitätsklinikum Freiburg
  • Gottingen, Germany, 37075
    • Recruiting
    • University Medicine Göttingen Germany
  • Hannover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitätsklinikum Leipzig
  • Münster, Germany, 48149
    • Recruiting
    • Universitätsklinikum Münster
  • Münster, Germany
    • Recruiting
    • Augenzentrum am St Franziskus-Hospital
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center - PPDS
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Medical Center
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center; Liver Inst.
  • Tel Aviv-Yafo, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center PPDS
• Italy
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Recruiting
      • Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
  • Lazio
    • Roma, Lazio, Italy
      • Recruiting
      • Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • Recruiting
      • Ospedale San Raffaele S.r.l. - PPDS
    • Milano, Lombardia, Italy, 20157
      • Recruiting
      • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
    • Milano, Lombardia, Italy, 20123
      • Recruiting
      • Ospedale S. Giuseppe Multimedica
• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Recruiting
    • Emanuelli Research and Development Center LLC
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72764
      • Recruiting
      • Retina Partners of Northwest Arkansas, PLLC
  • California
    • Beverly Hills, California, United States, 90211
      • Completed
      • Retina-Vitreous Associates Medical Group
    • Encino, California, United States, 91436
      • Recruiting
      • The Retina Partners
    • Fullerton, California, United States, 92835-3424
      • Recruiting
      • Retina Consultants of Orange County
    • Mountain View, California, United States, 94040
      • Recruiting
      • Northern California Retina Vitreous Associates
    • Poway, California, United States, 92064
      • Recruiting
      • Retina Consultants, San Diego
    • Sacramento, California, United States, 95825
      • Recruiting
      • Retinal Consultants Medical Group
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Eye Center
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Bay Area Retina Associates
  • Colorado
    • Durango, Colorado, United States, 81303
      • Recruiting
      • Southwest Retina Consultants
    • Longmont, Colorado, United States, 80503
      • Recruiting
      • Eye Care Center of Northern Colorado PC
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Recruiting
      • Advanced Research
    • Deerfield Beach, Florida, United States, 33064
      • Recruiting
      • Rand Eye Institute
    • Fort Myers, Florida, United States, 33912
      • Recruiting
      • National Ophthalmic Research Institute
    • Melbourne, Florida, United States, 32901
      • Recruiting
      • Florida Eye Associates
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • Southeast Retina Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Illinois Eye and Ear Infirmary
    • Oak Forest, Illinois, United States, 60452
      • Recruiting
      • University Retina and Macula Associates, PC
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Recruiting
      • Raj K. Maturi, MD PC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Recruiting
      • Wolfe Eye Clinic
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Recruiting
      • Cumberland Valley Retina Consultants PC
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • Recruiting
      • New England Retina Consultants
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Foundation for Vision Research
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Recruiting
      • Deep Blue Retina Clinical Research
  • Nevada
    • Reno, Nevada, United States, 89502
      • Recruiting
      • Sierra Eye Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Recruiting
      • Eye Associates of New Mexico
  • New York
    • Buffalo, New York, United States, 14209-2102
      • Withdrawn
      • Ross Eye Institute
    • New York, New York, United States, 10022
      • Recruiting
      • Vitreous Retina Macula Consultants of New York
    • Oceanside, New York, United States, 11572
      • Recruiting
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke Eye Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Cole Eye Institute
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Recruiting
      • Retina Vitreous Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Casey Eye Institute - OHSU
    • Portland, Oregon, United States, 97225
      • Recruiting
      • EyeHealth Northwest
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Recruiting
      • Erie Retinal Surgery
    • Kingston, Pennsylvania, United States, 18704
      • Withdrawn
      • Eye Care Specialists, PC
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Scheie Eye Institute
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Withdrawn
      • Charleston Neuroscience Institute
    • West Columbia, South Carolina, United States, 29169
      • Recruiting
      • Palmetto Retina Center, LLC
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • Charles Retina Institute
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Retina PC
    • Nashville, Tennessee, United States, 37232
      • Withdrawn
      • Vanderbilt Vision Research Center
  • Texas
    • Abilene, Texas, United States, 79606
      • Recruiting
      • W Texas Retina Consultants PA
    • Austin, Texas, United States, 78750
      • Recruiting
      • Austin Clinical Research LLC
    • Austin, Texas, United States, 78705-1169
      • Recruiting
      • Austin Retina Associates
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Retina Foundation of the Southwest
    • DeSoto, Texas, United States, 75115
      • Recruiting
      • Retina Specialists
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • San Antonio Eye Center
    • The Woodlands, Texas, United States, 77384-4167
      • Recruiting
      • Retina Consultants of Texas
  • Utah
    • Bountiful, Utah, United States, 84010
      • Withdrawn
      • Utah Eye Center
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • Rocky Mountain Retina
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Wagner Kapoor Institute
  • Washington
    • Spokane, Washington, United States, 99204
      • Recruiting
      • Spokane Eye Clinical Research
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Eye Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2275
      • Recruiting
      • University of Wisconsin Hospital and Clinics

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

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): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: GE43220; 2022-000046-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No