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
wAMD
A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
1 other identifier
interventional
400
1 country
76
Brief Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2024
Typical duration for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2024
CompletedFirst Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
May 4, 2026
May 1, 2026
1.8 years
October 30, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average change in best corrected visual acuity (BCVA)
Weeks 52 and 56
Secondary Outcomes (2)
Rate of injection burden
Week 56
Average change in best corrected visual acuity (BCVA)
Week 96
Study Arms (2)
EYP-1901 2686 µg
EXPERIMENTALEYP-1901
Aflibercept
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subfoveal fibrosis, atrophy, or scarring in the center subfield.
- BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Retinal Research Institute, LLC
Phoenix, Arizona, 85053, United States
Retina Partners of Northwest Arkansas
Springdale, Arkansas, 72764, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Macula and Retina Institute
Glendale, California, 91203, United States
Retina Consultants San Diego
Poway, California, 92064, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Retinal Consultants Medical Group
Sacramento, California, 95841, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
American Institute of Research
Whittier, California, 95008, United States
RSC Research, PLLC
Denver, Colorado, 80210, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528, United States
Advanced Vision Institute
Longmont, Colorado, 80503, United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, 06810, United States
SightSera Clinical Research LLC
Greenwich, Connecticut, 06830, United States
Retina Group of New England, PC
Waterford, Connecticut, 06385, United States
Advanced Research, LLC
Deerfield Beach, Florida, 33064, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
MedEye Associates
South Miami, Florida, 33143, United States
Retina Specialists of Tampa
Tampa, Florida, 33544, United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617, United States
Center for Retina & Macular Disease
Winter Haven, Florida, 33880, United States
Gerogia Retina
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Retina Associates
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates
Lemont, Illinois, 60439, United States
Midwest Eye Institute
Carmel, Indiana, 46290, United States
Retina Associates LLC
Lenexa, Kansas, 66215, United States
Maine Eye Center
Portland, Maine, 04101, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Retina Groups of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Retina Specialists
Towson, Maryland, 21204, United States
Ophthalmic Consultants of Boston OCB - Boston
Boston, Massachusetts, 02114, United States
New England Retina Consultants
Springfield, Massachusetts, 01107, United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439, United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546, United States
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, 38671, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
NJ Retina
Teaneck, New Jersey, 07666, United States
NJ Retina
Toms River, New Jersey, 08755, United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088, United States
Retina Associates of Western NY, PC
Rochester, New York, 14620, United States
Retina Consultants PLLC
Slingerlands, New York, 12159, United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, 28803, United States
Cape Fear Retinal Associates, PC
Wilmington, North Carolina, 28401, United States
Piedmont Retina Specialists, P.A. - Winston-Salem Office
Winston-Salem, North Carolina, 27103, United States
Tulsa Retina Consultant
Tulsa, Oklahoma, 74114, United States
Verum Research LLC
Eugene, Oregon, 97401, United States
Erie Retina Research
Erie, Pennsylvania, 16507, United States
Eye Care Specialists - Kingston Location
Kingston, Pennsylvania, 18704, United States
Retina Consultants
Charleston, South Carolina, 29414, United States
Palmetto Retina Center
Florence, South Carolina, 29169, United States
Retina Consultants of Carolina P.A
Greenville, South Carolina, 29605, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Retina Research Institute of Texas Integrated Clinical Research
Abilene, Texas, 79606, United States
Retina and Vitreous of Texas
Bellaire, Texas, 77401, United States
Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
Bellaire, Texas, 77401, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Texas Retina Associates
Plano, Texas, 75075, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Retinal Consultants of Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Tyler Retina Consultants
Tyler, Texas, 75703, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Salt Lake Retina
West Jordan, Utah, 84088, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Retina Associates, P.C.
Winchester, Virginia, 22601, United States
University of Wisconsin School of Medicine and Public Health (UWSMPH)
Madison, Wisconsin, 53705, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
October 31, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
May 4, 2026
Record last verified: 2026-05