Clinical trial NCT03972709: A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Official title: A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Degeneration, Age-Related
Geographic Atrophy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-04
Enrollment: 372
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 60 years at time of signing Informed Consent Form;
* Visual acuity: best-corrected visual acuity (BCVA) letter score \>/= 24 letters (Snellen equivalent of 20/320 or better). If the study eye 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);
* Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

Exclusion Criteria:

Ocular Exclusion Criteria, Study Eye:

* History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
* Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.

Ocular Exclusion Criteria, Both Eyes:

* GA in either eye due to causes other than AMD;
* Active uveitis and/or vitritis (grade trace or above) in either eye;
* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
* Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
* Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.

Primary outcomes:
measure: Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Percentage of Participants With Ocular Adverse Events in the Study Eye
timeFrame: From baseline to Week 76
measure: Percentage of Participants With Ocular Adverse Events in the Fellow Eye
timeFrame: From baseline to Week 76
measure: Percentage of Participants With Systemic Adverse Events
timeFrame: From baseline to Week 76
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: From baseline to Week 76
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From baseline to Week 76
measure: Percentage of Participants With Adverse Events Leading to Study Discontinuation
timeFrame: From baseline to Week 76
measure: Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions
timeFrame: Baseline, Week 72
measure: Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest PC
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
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: Los Angeles
country: United States
facility: Jules Stein Eye Institute/ UCLA
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: W Coast Retina Med Group Inc
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: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
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: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital.
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Mass Eye and Ear Infirmary
state: Massachusetts
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: Edina
country: United States
facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
state: Minnesota
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: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Cherry Hill
country: United States
facility: Mid Atlantic Retina
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Toms River
country: United States
facility: Retina Vitreous Center, PA
state: New Jersey
city: Hauppauge
country: United States
facility: Long Is. Vitreoretinal Consult
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Slingerlands
country: United States
facility: The Retina Consultants
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: Retina Assoc of Cleveland Inc
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Cole Eye Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Middleburg Heights
country: United States
facility: Retina Associates of Cleveland - Middleburg Heights Location
state: Ohio
city: Youngstown
country: United States
facility: Retina Associates of Cleveland - Youngstown Location
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: Abilene
country: United States
facility: Retina Res Institute of Texas
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: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina
state: Utah
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: