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

Age-Related Macular Degeneration Clinical Trial

— HONU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300724
• Other study ID #: GE43220
• Secondary ID: 2022-000046-15
• Status: Recruiting
• Start date: May 27, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: GE43220 https://forpatients.roche.com/
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 94 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• No intervention
No intervention will be administered in this study.

Locations

Country	Name	City	State
Australia	Adelaide Eye and Retina Centre	Adelaide	South Australia
Australia	Centre For Eye Research Australia	East Melbourne	Victoria
Australia	The Lions Eye Institute	Nedlands	Western Australia
Australia	Marsden Eye Specialists	Parramatta	New South Wales
Australia	Sydney Eye Hospital	Sydney	New South Wales
Australia	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales
France	Centre Hospitalier Intercommunal	Creteil
France	Centre Ophtalmologique Pole Vision	Ecully
France	CHU de GRENOBLE	Grenoble
France	Centre ophtalmologique Rabelais; Ophtalmologie	Lyon
France	Hôpital de La Croix Rousse	Lyon
France	Hopital Lariboisiere; Ophtalmologie	Paris
France	Hospital Foundation Adolphe De Rothschild	Paris
France	Centre Ophtalmologique Maison-Rouge	Strasbourg
Germany	Universitätsklinikum Bonn; Medizinische Klinik II, Zentrum für Integrative Medizin (ZIM)	Bonn
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	University Medicine Gottingen Germany	Gottingen
Germany	Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie	Hannover
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Augenzentrum am St Franziskus-Hospital	Münster
Germany	Universitatsklinikum Munster	Münster
Germany	Universitätsklinikum Tübingen	Tübingen
Israel	Rambam Medical Center - PPDS	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Rabin Medical Center; Liver Inst.	Petach Tikva
Israel	Tel Aviv Sourasky Medical Center PPDS	Tel Aviv-Yafo
Italy	ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco	Milano	Lombardia
Italy	Ospedale S. Giuseppe Multimedica	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico	Roma	Lazio
Italy	Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia	Udine	Friuli-Venezia Giulia
Puerto Rico	Emanuelli Research and Development Center LLC	Arecibo
United States	W Texas Retina Consultants PA	Abilene	Texas
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Clinical Research LLC	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Utah Eye Center	Bountiful	Utah
United States	Ross Eye Institute	Buffalo	New York
United States	Illinois Eye and Ear Infirmary	Chicago	Illinois
United States	Cleveland Clinic Cole Eye Institute	Cleveland	Ohio
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Advanced Research	Deerfield Beach	Florida
United States	Rand Eye Institute	Deerfield Beach	Florida
United States	Retina Specialists	DeSoto	Texas
United States	Southwest Retina Consultants	Durango	Colorado
United States	Duke Eye Center	Durham	North Carolina
United States	Retina Vitreous Center	Edmond	Oklahoma
United States	The Retina Partners	Encino	California
United States	Erie Retinal Surgery	Erie	Pennsylvania
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Retina Consultants of Orange County	Fullerton	California
United States	Charles Retina Institute	Germantown	Tennessee
United States	Foundation for Vision Research	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants PC	Hagerstown	Maryland
United States	Raj K. Maturi, MD PC	Indianapolis	Indiana
United States	Eye Care Specialists, PC	Kingston	Pennsylvania
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Eye Care Center of Northern Colorado PC	Longmont	Colorado
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Florida Eye Associates	Melbourne	Florida
United States	West Virginia University Eye Institute	Morgantown	West Virginia
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Vanderbilt Vision Research Center	Nashville	Tennessee
United States	Vitreous Retina Macula Consultants of New York	New York	New York
United States	Wagner Kapoor Institute	Norfolk	Virginia
United States	University Retina and Macula Associates, PC	Oak Forest	Illinois
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Casey Eye Institute - OHSU	Portland	Oregon
United States	EyeHealth Northwest	Portland	Oregon
United States	Retina Consultants, San Diego	Poway	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retinal Consultants Medical Group	Sacramento	California
United States	UC Davis Eye Center	Sacramento	California
United States	Rocky Mountain Retina	Salt Lake City	Utah
United States	San Antonio Eye Center	San Antonio	Texas
United States	Deep Blue Retina Clinical Research	Southaven	Mississippi
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Retina Partners of Northwest Arkansas, PLLC	Springdale	Arkansas
United States	New England Retina Consultants	Springfield	Massachusetts
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Bay Area Retina Associates	Walnut Creek	California
United States	Palmetto Retina Center, LLC	West Columbia	South Carolina
United States	Wolfe Eye Clinic	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Italy,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Conversion from iAMD to nGA /iRORA		Baseline up to 3 years
Primary	Rate of Conversion from nGA/iRORA to cRORA/GA		Baseline up to 3 years
Primary	Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)		Baseline up to 3 years