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
Overview
- Phase
- Phase 2
- Intervention
- Galegenimab
- Conditions
- Macular Degeneration, Age-Related
- Sponsor
- Genentech, Inc.
- Enrollment
- 144
- Locations
- 47
- Primary Endpoint
- Percentage of Participants With Ocular Adverse Events
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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).
Investigators
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
Arms & Interventions
Galegenimab 20 mg Q4W
Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).
Intervention: Galegenimab
Galegenimab 20 mg Q8W
Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).
Intervention: Galegenimab
Galegenimab 10 mg Q4W
Participants will receive 10 mg galegenimab via ITV injection Q4W.
Intervention: Galegenimab
Galegenimab 10 mg Q8W
Participants will receive 10 mg galegenimab via ITV injection Q8W.
Intervention: Galegenimab
Outcomes
Primary Outcomes
Percentage of Participants With Ocular Adverse Events
Time Frame: From baseline up to Week 104
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.
Percentage of Participants With Systemic (Non-Ocular) Adverse Events
Time Frame: From Baseline up to Week 104
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.