Clinical trial NCT04607148: A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Degeneration, Age-Related
Geographic Atrophy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).


Eligibility criteria: Inclusion Criteria:

* Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.

Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.

Ocular Inclusion Criteria: Non-Study Eye

- The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.

Exclusion Criteria:

Ocular Exclusion Criteria:

* Active uveitis and/or vitritis (grade trace or above) in either eye
* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment
* Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye
* Retinal pigment epithelium (RPE) tear that involves the macula in either eye
* Moderate or severe non-proliferative diabetic retinopathy in either eye
* Proliferative diabetic retinopathy in either eye
* Central serous retinopathy in either eye
* Recent history of recurrent infectious or inflammatory ocular disease in either eye
* Recent history of idiopathic or autoimmune-associated uveitis in either eye
* Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.

Primary outcomes:
measure: Percentage of Participants With Ocular Adverse Events
timeFrame: From baseline up to Week 104
measure: Percentage of Participants With Systemic (Non-Ocular) Adverse Events
timeFrame: From Baseline up to Week 104
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
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: Retinal Consultants Med Group
state: California
city: San Francisco
country: United States
facility: West Coast Retina
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Santa Maria
country: United States
facility: California Retina Consultants - Santa Maria
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado PC
state: Colorado
city: Durango
country: United States
facility: Southwest Retina Consultants
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates - Melbourne 2nd Office
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Assoc of FL
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: Chicago
country: United States
facility: Illinois Eye and Ear Infirmary
state: Illinois
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Wichita
country: United States
facility: Vitreo Retinal Consultants
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants PC
state: Michigan
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Toms River
country: United States
facility: NJ Retina Teaneck Clinic
state: New Jersey
city: Toms River
country: United States
facility: NJ Retina-Toms River
state: New Jersey
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates PA
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Cole Eye Institute
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Retina Associates Chattanooga
state: Tennessee
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: