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

Genentech

Status and phase: Terminated; Phase 2

Conditions: Geographic Atrophy; Macular Degeneration, Age-Related

Treatments: Drug: Galegenimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04607148

GR42558

Details and patient eligibility

About

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).

Enrollment: 144 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 4 patient groups

Galegenimab 20 mg Q4W

Experimental group

Description:

Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).

Treatment:

Drug: Galegenimab

Galegenimab 20 mg Q8W

Experimental group

Description:

Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).

Treatment:

Drug: Galegenimab

Galegenimab 10 mg Q4W

Experimental group

Description:

Participants will receive 10 mg galegenimab via ITV injection Q4W.

Treatment:

Drug: Galegenimab

Galegenimab 10 mg Q8W

Experimental group

Description:

Participants will receive 10 mg galegenimab via ITV injection Q8W.

Treatment:

Drug: Galegenimab