Select Your Region
Global
Testing a new medicine (galegenimab) to find out if it is effective for a type of eye disease (geographic atrophy secondary to age-related macular degeneration)
A Study Assessing the Safety, Tolerability, and Efficacy of RO7171009 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
- 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
Cities
- Abilene
- Augusta
- Austin
- Bakersfield
- Baltimore
- Beachwood
- Beverly Hills
- Bloomfield
- Boston
- Charlotte
- Chattanooga
- Cherry Hill
- Chesterfield
- Chevy Chase
- Chicago
- Cincinnati
- Cleveland
- Colorado Springs
- Columbus
- Dallas
- Durango
- Edina
- Fullerton
- Germantown
- Grand Rapids
- Hagerstown
- Hauppauge
- Lakewood
- Los Angeles
- Madison
- Marietta
- Middleburg Heights
- Mountain View
- Nashville
- Oak Forest
- Pennsylvania
- Pensacola
- Philadelphia
- Phoenix
- Pompano Beach
- Portland
- Poway
- Reno
- Rochester
- Royal Oak
- Sacramento
- Salt Lake City
- San Antonio
- San Francisco
- Santa Barbara
- Santa Maria
- shenandoah
- Slingerlands
- Spokane
- St. Louis
- St. Petersburg
- Tallahassee
- Teaneck
- The Woodlands
- Toms River
- Tucson
- valley-stream
- Walnut Creek
- West Des Moines
- west-columbia
- Wichita
- Youngstown
Trial Identifier:
NCT03972709 GR40973
Trial Summary
This clinical trial was done to find out if a new medicine called, “galegenimab,” was effective for the treatment of patients with a type of eye disease (geographic atrophy [GA] secondary to age-related macular degeneration [AMD]). This was a phase 2, randomized, sham-controlled study to assess the efficacy, safety, and tolerability of eye injections (intravitreal injections) given to patients with GA secondary to AMD. The study took place at 77 study centers at 71 study sites in one country – the USA.
Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)
Sponsor
Phase 2
Phase
NCT03972709, GR40973
Trial Identifier
Galegenimab, 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.
For the latest version of this information please go to www.forpatients.roche.com