A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Condition: Macular Degeneration, Age-Related; Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Galegenimab
Intervention description: Intravitreal (ITV) injections of galegenimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design. The Outcome Assessor is masked for BCVA assessments.
Enrollment: 144.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

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).
    

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

          -  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.