A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
TerminatedPhase 2Results postedLast updated 16 October 2023
What this trial tests
Phase 2 trial testing Galegenimab in Macular Degeneration, Age-Related in 144 participants. Terminated before completion.
60 and older, any sex, with Macular Degeneration, Age-Related or Geographic Atrophy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Ocular Adverse EventsPrimary· From baseline up to Week 104
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.
Group
Value
95% CI
Galegenimab 10MG Q4W
50
Galegenimab 20MG Q4W
42.9
Galegenimab 10MG Q8W
25
Galegenimab 20MG Q8W
27.1
Percentage of Participants With Systemic (Non-Ocular) Adverse EventsPrimary· From Baseline up to Week 104
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.
Group
Value
95% CI
Galegenimab 10MG Q4W
71.4
Galegenimab 20MG Q4W
70
Galegenimab 10MG Q8W
33.3
Galegenimab 20MG Q8W
47.9
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline up to Week 104.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT03972709 — A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrop
· Phase 2
· terminated
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 16 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04607148.