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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Macular Degeneration, Age-Related, Geographic Atrophy

Intervention / Treatment
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* Drug: Galegenimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galegenimab 20 mg Q4W<br>Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W). | Drug: Galegenimab<br>* Intravitreal (ITV) injections of galegenimab<br>* Other names: FHTR2163;|
| Experimental: Galegenimab 20 mg Q8W<br>Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W). | Drug: Galegenimab<br>* Intravitreal (ITV) injections of galegenimab<br>* Other names: FHTR2163;|
| Experimental: Galegenimab 10 mg Q4W<br>Participants will receive 10 mg galegenimab via ITV injection Q4W. | Drug: Galegenimab<br>* Intravitreal (ITV) injections of galegenimab<br>* Other names: FHTR2163;|
| Experimental: Galegenimab 10 mg Q8W<br>Participants will receive 10 mg galegenimab via ITV injection Q8W. | Drug: Galegenimab<br>* Intravitreal (ITV) injections of galegenimab<br>* Other names: FHTR2163;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |