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The long-term study of a new medicine (galegenimab) in people with a type of eye disease (geographic atrophy secondary to age-related macular degeneration)
A Study Assessing the Long-Term Safety and Tolerability of RG6147 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- Eye Disorder
- Macular Degeneration
- Age-Related Macular Degeneration
- Dry Macular Degeneration
- Geographic Atrophy
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Terminated
This trial runs in
Country
- United States
Trial Identifier:
NCT04607148 GR42558
Trial Summary
This clinical trial investigated a new medicine called “galegenimab.” People with a type of eye disease, “geographic atrophy secondary to age-related macular degeneration,” joined this study to find out if galegenimab treatments were safe and tolerable when given over a long time. Injections were given in the study eye, once every 4 or 8 weeks. The study treatment was planned for about 3 years. People underwent detailed eye examinations throughout the study. They were monitored for side effects, taking into consideration their nature, frequency, and severity.
Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)
Sponsor
Phase 2
Phase
NCT04607148,GR42558
Trial Identifier
Galegenimab
Treatments
Macular Degeneration, Age-Related, Geographic Atrophy
Condition
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
Eligibility Criteria
All
Gender
≥60 Years
Age
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.
For the latest version of this information please go to www.forpatients.roche.com