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

Geographic Atrophy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04607148
• Other study ID #: GR42558
• Status: Terminated
• Phase: Phase 2
• Start date: November 16, 2020
• Est. completion date: November 14, 2022

Study information

• Verified date: October 2023
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Galegenimab
Intravitreal (ITV) injections of galegenimab

Locations

Country	Name	City	State
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 University	Baltimore	Maryland
United States	Charlotte Eye Ear Nose and Throat Associates PA	Charlotte	North Carolina
United States	Southeastern Retina Associates Chattanooga	Chattanooga	Tennessee
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
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 Consultants of Southern Colorado PC	Colorado Springs	Colorado
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	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	Colorado Retina Associates, PC	Lakewood	Colorado
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	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC	Nashville	Tennessee
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	Casey Eye Institute	Portland	Oregon
United States	Retina Consultants, San Diego	Poway	California
United States	Sierra Eye Associates	Reno	Nevada
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	West Coast Retina	San Francisco	California
United States	California Retina Consultants	Santa Barbara	California
United States	California Retina Consultants - Santa Maria	Santa Maria	California
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Southern Vitreoretinal Associates	Tallahassee	Florida
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	NJ Retina Teaneck Clinic	Toms River	New Jersey
United States	NJ Retina-Toms River	Toms River	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Ocular 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. Ocular AEs are the events which are localized in the ocular region.	From baseline up to Week 104
Primary	Percentage of Participants With Systemic (Non-Ocular) 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.	From Baseline up to Week 104