A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
\- 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.
You may not be if
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.
Clareo Health | A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration