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Monoclonal Antibodies
Galegenimab 20 mg Q4W for Age-Related Macular Degeneration
Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, weeks 24, 48, 72, 96, 144 and uv (up to week 148)
Awards & highlights
Study Summary
This trial will evaluate the long-term safety of a new drug given by injections into the eye, every 4 or 8 weeks, for people with a certain kind of vision loss due to age-related macular degeneration.
Eligible Conditions
- Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
The patient's eyes were clear and their pupils were dilated adequately to allow for a good image of the fundus.
Select...
If the study eye has a BCVA of ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of the parent study.
Select...
If the study eye has a BCVA letter score of ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of the parent study, the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, weeks 24, 48, 72, 96, 144 and uv (up to week 148)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, weeks 24, 48, 72, 96, 144 and uv (up to week 148)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Ocular Adverse Events
Percentage of Participants With Systemic (Non-Ocular) Adverse Events
Secondary outcome measures
Aqueous Humor Concentration of FHTR2163
Aqueous Humor Concentration of RG6147
Percentage of Participants With Anti-Drug Antibodies to FHTR2163
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Galegenimab 20 mg Q8WExperimental Treatment1 Intervention
Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).
Group II: Galegenimab 20 mg Q4WExperimental Treatment1 Intervention
Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).
Group III: Galegenimab 10 mg Q8WExperimental Treatment1 Intervention
Participants will receive 10 mg galegenimab via ITV injection Q8W.
Group IV: Galegenimab 10 mg Q4WExperimental Treatment1 Intervention
Participants will receive 10 mg galegenimab via ITV injection Q4W.
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,536 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,416 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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