A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Geographic Atrophy Clinical Trial

— GALLEGO  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03972709
• Other study ID #: GR40973
• Status: Terminated
• Phase: Phase 2
• Start date: June 3, 2019
• Est. completion date: October 27, 2022

Study information

• Verified date: March 2024
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 372
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration
• Macular Degeneration, Age-Related

Intervention

Drug:
• Galegenimab
Intravitreal (ITV) injections of galegenimab
• Sham Control
Sham control

Locations

Country	Name	City	State
United States	Retina Res Institute of Texas	Abilene	Texas
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Clinical Research LLC	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Johns Hopkins Hospital.	Baltimore	Maryland
United States	The Retina Care Center	Baltimore	Maryland
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Envision Ocular, LLC	Bloomfield	New Jersey
United States	Mass Eye and Ear Infirmary	Boston	Massachusetts
United States	Charlotte Eye Ear Nose and Throat Associates PA	Charlotte	North Carolina
United States	Southeastern Retina Associates Chattanooga	Chattanooga	Tennessee
United States	Mid Atlantic Retina	Cherry Hill	New Jersey
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	Illinois Eye and Ear Infirmary	Chicago	Illinois
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Cleveland Clinic Foundation; Cole Eye Institute	Cleveland	Ohio
United States	Retina Assoc of Cleveland Inc	Cleveland	Ohio
United States	Retina Consultants of Southern Colorado PC	Colorado Springs	Colorado
United States	Ohio State University	Columbus	Ohio
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Rand Eye	Deerfield Beach	Florida
United States	Southwest Retina Consultants	Durango	Colorado
United States	VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota	Edina	Minnesota
United States	The Retina Partners	Encino	California
United States	Retina Consultants of Orange County	Fullerton	California
United States	Charles Retina Institute	Germantown	Tennessee
United States	Vitreo-Retinal Associates	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Long Is. Vitreoretinal Consult	Hauppauge	New York
United States	Colorado Retina Associates, PC	Lakewood	Colorado
United States	Jules Stein Eye Institute/ UCLA	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Georgia Retina PC	Marietta	Georgia
United States	Florida Eye Associates - Melbourne 2nd Office	Melbourne	Florida
United States	Retina Associates of Cleveland - Middleburg Heights Location	Middleburg Heights	Ohio
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC	Nashville	Tennessee
United States	University Retina and Macula Associates, PC	Oak Forest	Illinois
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Retina Specialty Institute	Pensacola	Florida
United States	Mid Atlantic Retina - Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Arizona Retina and Vitreous Consultants	Phoenix	Arizona
United States	Casey Eye Institute	Portland	Oregon
United States	Maine Eye Center	Portland	Maine
United States	Retina Consultants, San Diego	Poway	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Associates of Western New York	Rochester	New York
United States	Associated Retinal Consultants PC	Royal Oak	Michigan
United States	Retinal Consultants Med Group	Sacramento	California
United States	The Retina Institute	Saint Louis	Missouri
United States	Retina Vitreous Assoc of FL	Saint Petersburg	Florida
United States	Rocky Mountain Retina	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	W Coast Retina Med Group Inc	San Francisco	California
United States	California Retina Consultants	Santa Barbara	California
United States	California Retina Consultants - Santa Maria	Santa Maria	California
United States	The Retina Consultants	Slingerlands	New York
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Southern Vitreoretinal Associates	Tallahassee	Florida
United States	Retina Associates of NJ	Teaneck	New Jersey
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Retina Vitreous Center, PA	Toms River	New Jersey
United States	Retina Associates Southwest PC	Tucson	Arizona
United States	Bay Area Retina Associates	Walnut Creek	California
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Wolfe Eye Clinic	West Des Moines	Iowa
United States	Vitreo Retinal Consultants	Wichita	Kansas
United States	Retina Associates of Cleveland - Youngstown Location	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)	GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).	Baseline, Week 72
Secondary	Percentage of Participants With Ocular Adverse Events in the Study Eye	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.	From baseline to Week 76
Secondary	Percentage of Participants With Ocular Adverse Events in the Fellow Eye	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.	From baseline to Week 76
Secondary	Percentage of Participants With Systemic Adverse Events	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.	From baseline to Week 76
Secondary	Percentage of Participants With Serious Adverse Events (SAEs)	SAEs are defined as fatal, life threatening, requires or prolongs patient hospitalization, results in persistent or significant disability/incapacity, or is a significant medical event in the investigator's judgement.	From baseline to Week 76
Secondary	Percentage of Participants With Adverse Events of Special Interest (AESIs)	AESIs include 1.) cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law 2.) Suspected transmission of an infectious agent by galegenimab 3.) AEs resulting from medication error 4.) Sight-threatening AEs of the following criteria: It causes a decrease of >= 30 letters in visual acuity (VA) score, compared with the most recent prior VA assessment, that lasts more than 1 hour and is attributable to galegenimab; it requires surgical intervention to prevent permanent loss of sight; associated with severe (Grade 4+) intraocular inflammation (IOI) and/or IOI-associated retinal vasculitis; in the opinion of the investigator, it may require medical intervention to prevent permanent loss of sight.	From baseline to Week 76
Secondary	Percentage of Participants With Adverse Events Leading to Study Discontinuation	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.	From baseline to Week 76
Secondary	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	BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m) under low-luminance conditions. A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.	Baseline, Week 72
Secondary	Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart	BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.	Baseline, Week 72