A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56
- Conditions
- Wet Age Related Macular DegenerationwAMD
- Interventions
- Registration Number
- NCT06668064
- Lead Sponsor
- EyePoint Pharmaceuticals, Inc.
- Brief Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
- Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
- For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.
- Subfoveal fibrosis, atrophy, or scarring in the center subfield.
- BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aflibercept Aflibercept (2.0 mg) - EYP-1901 2686 µg EYP-1901 EYP-1901
- Primary Outcome Measures
Name Time Method Average change in best corrected visual acuity (BCVA) Weeks 52 and 56
- Secondary Outcome Measures
Name Time Method Rate of injection burden Week 56 Average change in best corrected visual acuity (BCVA) Week 96
Trial Locations
- Locations (79)
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Retina Partners of Northwest Arkansas
🇺🇸Springdale, Arkansas, United States
California Retina Consultants
🇺🇸Bakersfield, California, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Macula and Retina Institute
🇺🇸Glendale, California, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
American Institute of Research
🇺🇸Whittier, California, United States
RSC Research, PLLC
🇺🇸Denver, Colorado, United States
Eye Center of Northern Colorado, PC
🇺🇸Fort Collins, Colorado, United States
Advanced Vision Institute
🇺🇸Longmont, Colorado, United States
Connecticut Eye Consultants, P.C.
🇺🇸Danbury, Connecticut, United States
SightSera Clinical Research LLC
🇺🇸Greenwich, Connecticut, United States
Retina Group of New England, PC
🇺🇸Waterford, Connecticut, United States
Advanced Research, LLC
🇺🇸Deerfield Beach, Florida, United States
Vitreo Retinal Associates
🇺🇸Gainesville, Florida, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Florida Retina Institute
🇺🇸Orlando, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
Retina Group of Florida
🇺🇸Sarasota, Florida, United States
MedEye Associates
🇺🇸South Miami, Florida, United States
Retina Specialists of Tampa
🇺🇸Tampa, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Tampa, Florida, United States
Center for Retina & Macular Disease
🇺🇸Winter Haven, Florida, United States
Gerogia Retina
🇺🇸Marietta, Georgia, United States
Retina Consultants of Hawaii
🇺🇸Aiea, Hawaii, United States
Retina Associates
🇺🇸Elmhurst, Illinois, United States
University Retina and Macula Associates
🇺🇸Lemont, Illinois, United States
Midwest Eye Institute
🇺🇸Carmel, Indiana, United States
Retina Associates LLC
🇺🇸Lenexa, Kansas, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Retina Groups of Washington
🇺🇸Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Retina Specialists
🇺🇸Towson, Maryland, United States
Ophthalmic Consultants of Boston OCB - Boston
🇺🇸Boston, Massachusetts, United States
New England Retina Consultants
🇺🇸Springfield, Massachusetts, United States
Retina Associates of Michigan
🇺🇸Grand Blanc, Michigan, United States
Foundation for Vision Research
🇺🇸Grand Rapids, Michigan, United States
Deep Blue Retina Clinical Research PLLC
🇺🇸Southaven, Mississippi, United States
The Retina Institute
🇺🇸St Louis, Missouri, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
NJ Retina
🇺🇸Toms River, New Jersey, United States
Vision Research Center at Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Retina Vitreous Surgeons of CNY, PC
🇺🇸Liverpool, New York, United States
Retina Associates of Western NY, PC
🇺🇸Rochester, New York, United States
Retina Consultants PLLC
🇺🇸Slingerlands, New York, United States
Western Carolina Retinal Associates, PA
🇺🇸Asheville, North Carolina, United States
Cape Fear Retinal Associates, PC
🇺🇸Wilmington, North Carolina, United States
Piedmont Retina Specialists, P.A. - Winston-Salem Office
🇺🇸Winston Salem, North Carolina, United States
Tulsa Retina Consultant
🇺🇸Tulsa, Oklahoma, United States
Verum Research LLC
🇺🇸Eugene, Oregon, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Eye Care Specialists - Kingston Location
🇺🇸Kingston, Pennsylvania, United States
Retina Consultants
🇺🇸Charleston, South Carolina, United States
Palmetto Retina Center
🇺🇸Florence, South Carolina, United States
Retina Consultants of Carolina P.A
🇺🇸Greenville, South Carolina, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Retina Research Institute of Texas Integrated Clinical Research
🇺🇸Abilene, Texas, United States
Retina and Vitreous of Texas
🇺🇸Bellaire, Texas, United States
Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
🇺🇸Bellaire, Texas, United States
Texas Retina Associates
🇺🇸Plano, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Retinal Consultants of Texas
🇺🇸San Antonio, Texas, United States
Retina Center of Texas
🇺🇸Southlake, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Tyler Retina Consultants
🇺🇸Tyler, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Salt Lake Retina
🇺🇸West Jordan, Utah, United States
The Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Retina Associates, P.C.
🇺🇸Winchester, Virginia, United States
University of Wisconsin School of Medicine and Public Health (UWSMPH)
🇺🇸Madison, Wisconsin, United States