This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Intravitreal injection
Sham injection
Associated Retina Consultants - Peoria- Site Number : 8400011
Peoria, Arizona, United States
RECRUITINGRetina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, United States
RECRUITINGVitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, United States
RECRUITINGRetina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida, United States
RECRUITINGUniversity Retina - Lemont- Site Number : 8400005
Lemont, Illinois, United States
RECRUITINGThe Retina Group of Washington - Chevy Chase- Site Number : 8400009
Chevy Chase, Maryland, United States
RECRUITINGCumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland, United States
RECRUITINGOregon Retina- Site Number : 8400017
Eugene, Oregon, United States
RECRUITINGMid Atlantic Retina- Site Number : 8400031
Bethlehem, Pennsylvania, United States
RECRUITINGAustin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas, United States
RECRUITING...and 3 more locations
Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Week 104
Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)
Time frame: Day 1 to Week 104
Change in square root-transformed (mm) and untransformed area (mm2) of GA
Time frame: Baseline, Week 52, Week 104
Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame: Baseline, Week 52, Week 104
Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye
Time frame: Baseline, Week 52, Week 104
Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters
Time frame: Week 260 or End of Study
Trial Transparency email recommended (Toll free for US & Canada)
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