A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
- Conditions
- Wet Age Related Macular DegenerationwAMD
- Interventions
- Registration Number
- NCT06683742
- 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 EYP-1901 2686 µg EYP-1901 EYP-1901 Aflibercept Aflibercept (2.0 mg) -
- 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 (71)
Associated Retina Consultans
🇺🇸Gilbert, Arizona, United States
Associated Retina Consultants - Phoenix
🇺🇸Phoenix, Arizona, United States
Phoenix Retina Clinical Trials, LLC
🇺🇸Phoenix, Arizona, United States
Retina Macula Institute of Arizona
🇺🇸Scottsdale, Arizona, United States
Win Retina
🇺🇸Arcadia, California, United States
Doctor Retina, PC
🇺🇸Beverly Hills, California, United States
The Retina Partners
🇺🇸Encino, California, United States
RCOC Clinical Research Institute Inc.
🇺🇸Fullerton, California, United States
Global Research Management, Inc.
🇺🇸Glendale, California, United States
Atlantis Eyecare
🇺🇸Huntington Beach, California, United States
South Coast Retina Center
🇺🇸Long Beach, California, United States
Retinal Consultants Medical Group
🇺🇸Modesto, California, United States
Northern California Retina Vitreous Associates Medical Group INC.
🇺🇸Mountain View, California, United States
Kaiser Permanente
🇺🇸Oakland, California, United States
California Retina Consultants Oxnard Office
🇺🇸Oxnard, California, United States
California Eye Specialists Medical Group, Inc.
🇺🇸Redlands, California, United States
SCPMG/Kaiser Permanente Riverside Medical Center
🇺🇸Riverside, California, United States
VRMG Inc
🇺🇸Sacramento, California, United States
Macula Retina Vitreous Research Institute
🇺🇸Torrance, California, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
Colorado Retina Associates
🇺🇸Lakewood, Colorado, United States
Blue Ocean Clinical Research
🇺🇸Clearwater, Florida, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
The Eye Institute of West Florida
🇺🇸Largo, Florida, United States
Retina Care Specialists
🇺🇸Palm Beach Gardens, Florida, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
Retina Vitreous Associates of Florida - Saint Petersburg
🇺🇸St. Petersburg, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Gailey Eye Clinic
🇺🇸Bloomington, Illinois, United States
Illinois Retina Associates, S.C.
🇺🇸Oak Park, Illinois, United States
AVRUC
🇺🇸Carmel, Indiana, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
Retina Associates New Orleans
🇺🇸Metairie, Louisiana, United States
Haik Humble Eye Center
🇺🇸West Monroe, Louisiana, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Mid Atlantic Retina Specialists
🇺🇸Hagerstown, Maryland, United States
Vitreo-Retinal Associates, PC
🇺🇸Worcester, Massachusetts, United States
Discover Vision Center
🇺🇸Independence, Missouri, United States
Envision Ocular, LLC
🇺🇸Bloomfield, New Jersey, United States
Mid Atlantic Retina
🇺🇸Cherry Hill, New Jersey, United States
NJ Retina
🇺🇸Edison, New Jersey, United States
NYC Retina
🇺🇸New York, New York, United States
VRCNY/Long Island Vitreoretinal Consultants
🇺🇸Westbury, New York, United States
Graystone Eye - Hickory Office
🇺🇸Hickory, North Carolina, United States
North Carolina Retina Associates
🇺🇸Wake Forest, North Carolina, United States
Retina Vitreous Center, PLLC
🇺🇸Edmond, Oklahoma, United States
Cascade Medical Research lnstitute, LLC
🇺🇸Springfield, Oregon, United States
Wills Eye Physician Mid Atlantic Retina
🇺🇸Bethlehem, Pennsylvania, United States
Retina Vitreous Consultants (RVC) - Monroeville
🇺🇸Monroeville, Pennsylvania, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Tennessee Retina
🇺🇸Nashville, Tennessee, United States
Panhandle Eye Group, LLP. - Southwest Retina Specialists
🇺🇸Amarillo, Texas, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
TX RCTX Retina Consultants of Texas
🇺🇸San Antonio, Texas, United States
Star Vision Research
🇺🇸Burleson, Texas, United States
Retina of North Texas
🇺🇸Dallas, Texas, United States
Berkeley Eye Center
🇺🇸Houston, Texas, United States
Retina Consultants of Texas
🇺🇸Katy, Texas, United States
Valley Retina Institute P.A.
🇺🇸Mcallen, Texas, United States
Red River Research Partners, LLC
🇺🇸Plano, Texas, United States
Retina Associates of South Texas
🇺🇸San Antonio, Texas, United States
Emerson Clinical Research Institute
🇺🇸Falls Church, Virginia, United States
Virginia Retina Center
🇺🇸Warrenton, Virginia, United States
Pacific Northwest Retina
🇺🇸Bellevue, Washington, United States