Clinical trial NCT05300724: An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Official title: A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Age-Related Macular Degeneration
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll participants with high risk intermediate AMD.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Conversion from iAMD to nGA /iRORA
timeFrame: Baseline up to 3 years
measure: Rate of Conversion from nGA/iRORA to cRORA/GA
timeFrame: Baseline up to 3 years
measure: Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
timeFrame: Baseline up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Retina Partners of Northwest Arkansas, PLLC
state: Arkansas
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Poway
country: United States
facility: Retina Consultants, San Diego
state: California
city: Sacramento
country: United States
facility: UC Davis Eye Center
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Durango
country: United States
facility: Southwest Retina Consultants
state: Colorado
city: Longmont
country: United States
facility: Eye Care Center of Northern Colorado PC
state: Colorado
city: Coral Springs
country: United States
facility: Advanced Research
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD PC
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants PC
state: Maryland
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Southaven
country: United States
facility: Deep Blue Retina Clinical Research
state: Mississippi
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Cole Eye Institute
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Portland
country: United States
facility: Casey Eye Institute - OHSU
state: Oregon
city: Erie
country: United States
facility: Erie Retinal Surgery
state: Pennsylvania
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center, LLC
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Abilene
country: United States
facility: W Texas Retina Consultants PA
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: DeSoto
country: United States
facility: Retina Specialists
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina
state: Utah
city: Norfolk
country: United States
facility: Wagner Kapoor Institute
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
state: South Australia
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal
city: Ecully
country: France
facility: Centre Ophtalmologique Pole Vision
city: Grenoble
country: France
facility: CHU de GRENOBLE
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Strasbourg
country: France
facility: Centre Ophtalmologique Maison-Rouge
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gottingen
country: Germany
facility: University Medicine Gottingen Germany
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Münster
country: Germany
facility: Augenzentrum am St Franziskus-Hospital
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Jerusalem
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico
state: Lazio
city: Milano
country: Italy
facility: Ospedale S. Giuseppe Multimedica
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
state: Lombardia
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center LLC
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: