A Study Assessing the Safety, Tolerability, and Efficacy of RO7171009 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
- Age-Related Macular Degeneration
Trial Status:
Recruiting
This trial runs in
Cities
- Abilene
- Asheville
- Ashland
- Augusta
- Austin
- Bakersfield
- Baltimore
- Beachwood
- Bellaire
- Beverly Hills
- Bloomfield
- Blue Ash
- Boston
- Charlotte
- Chattanooga
- Chesterfield
- Chevy Chase
- Chicago
- Cleveland
- Colorado Springs
- Columbus
- Dallas
- Durango
- Edina
- Florence
- Fullerton
- Germantown
- Grand Rapids
- Great Neck
- Hagerstown
- Lakewood
- Leawood
- Los Angeles
- Madison
- Marietta
- Melbourne
- Middleburg Heights
- Mountain View
- Murray
- Nashville
- Norfolk
- Oak Forest
- Pensacola
- Philadelphia
- Phoenix
- Pompano Beach
- Portland
- Poway
- Reno
- Rochester
- Rockville Centre
- Royal Oak
- Sacramento
- San Antonio
- San Francisco
- Santa Barbara
- Santa Maria
- Slingerlands
- Spokane
- St. Louis
- St. Petersburg
- Tallahassee
- Teaneck
- The Woodlands
- Toms River
- Tucson
- Walnut Creek
- West Des Moines
- Wichita
- Winston-Salem
- Youngstown
Trial Identifier:
NCT03972709 GR40973
Trial Summary
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of FHTR2163 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT03972709 (GR42558) and receive open-label FHTR2163 injections.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT03972709 , GR40973
Trial Identifier
FHTR2163, Sham Control
Treatments
Macular Degeneration, Age-Related, Geographic Atrophy
Condition
Official Title
A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)
Eligibility Criteria
All
Gender
≥60 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Age >/= 60 years at time of signing Informed Consent Form;
- Visual acuity: best-corrected visual acuity (BCVA) letter score >/= 24 letters (Snellen equivalent of 20/320 or better). If the study eye 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);
- Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.
Exclusion Criteria
Ocular Exclusion Criteria, Study Eye:
- History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
- Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.
Ocular Exclusion Criteria, Both Eyes:
- GA in either eye due to causes other than AMD;
- Active uveitis and/or vitritis (grade trace or above) in either eye;
- Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
- Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
- Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.
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