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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by EyePoint Pharmaceuticals, Inc.
Sponsor
EyePoint Pharmaceuticals, Inc.
Information Provided by (Responsible Party)
EyePoint Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT06668064
Other Study ID Numbers:
EYP-1901-301
First Submitted
October 29, 2024
First Posted
October 30, 2024
Last Update Posted
April 1, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Wet Age Related Macular DegenerationwAMD
Drug: EYP-1901Drug: Aflibercept (2.0 mg)

Study Design

Study TypeInterventional
Actual Enrollment400 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateOctober 21, 2024
Actual Primary Completion Date3mos 2w from now
Actual Study Completion Date1yr 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
EYP-1901 2686 µg
EYP-1901
Drug: EYP-1901
Intravitreal Injection
Aflibercept
Drug: Aflibercept (2.0 mg)
Intravitreal Injection

Outcome Measures

Primary Outcome Measures
  1. Average change in best corrected visual acuity (BCVA)
Secondary Outcome Measures
  1. Rate of injection burden
  2. Average change in best corrected visual acuity (BCVA)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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.
Exclusion Criteria
Subfoveal fibrosis, atrophy, or scarring in the center subfield.
BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.

Contacts and Locations

Sponsors and CollaboratorsEyePoint Pharmaceuticals, Inc.
Locations
Retinal Research Institute, LLC | Phoenix Arizona, United States, 85053Retina Partners of Northwest Arkansas | Springdale Arkansas, United States, 72764California Retina Consultants | Bakersfield California, United States, 93309Retina Vitreous Associates Medical Group | Beverly Hills California, United States, 90211Macula and Retina Institute | Glendale California, United States, 91203Retina Consultants San Diego | Poway California, United States, 92064Retina Consultants of Southern California | Redlands California, United States, 92374Retinal Consultants Medical Group | Sacramento California, United States, 95841West Coast Retina Medical Group | San Francisco California, United States, 94109Bay Area Retina Associates | Walnut Creek California, United States, 94598American Institute of Research | Whittier California, United States, 95008RSC Research, PLLC | Denver Colorado, United States, 80210Eye Center of Northern Colorado, PC | Fort Collins Colorado, United States, 80528Advanced Vision Institute | Longmont Colorado, United States, 80503Connecticut Eye Consultants, P.C. | Danbury Connecticut, United States, 06810SightSera Clinical Research LLC | Greenwich Connecticut, United States, 06830Retina Group of New England, PC | Waterford Connecticut, United States, 06385Advanced Research, LLC | Deerfield Beach Florida, United States, 33064Florida Retina Consultants | Lakeland Florida, United States, 33805Florida Retina Institute | Orlando Florida, United States, 32806Retina Specialty Institute | Pensacola Florida, United States, 32503Eye Associates of Pinellas | Pinellas Park Florida, United States, 33782Retina Group of Florida | Sarasota Florida, United States, 34232MedEye Associates | South Miami Florida, United States, 33143Retina Specialists of Tampa | Tampa Florida, United States, 33544Retina Vitreous Associates of Florida | Tampa Florida, United States, 33617Center for Retina & Macular Disease | Winter Haven Florida, United States, 33880Gerogia Retina | Marietta Georgia, United States, 30060Retina Consultants of Hawaii | ‘Aiea Hawaii, United States, 96701Retina Associates | Elmhurst Illinois, United States, 60126University Retina and Macula Associates | Lemont Illinois, United States, 60439Midwest Eye Institute | Carmel Indiana, United States, 46290Retina Associates LLC | Lenexa Kansas, United States, 66215Maine Eye Center | Portland Maine, United States, 04101The Retina Care Center | Baltimore Maryland, United States, 21209Retina Groups of Washington | Chevy Chase Maryland, United States, 20815Cumberland Valley Retina Consultants | Hagerstown Maryland, United States, 21740Retina Specialists | Towson Maryland, United States, 21204Ophthalmic Consultants of Boston OCB - Boston | Boston Massachusetts, United States, 02114New England Retina Consultants | Springfield Massachusetts, United States, 01107Retina Associates of Michigan | Grand Blanc Michigan, United States, 48439Foundation for Vision Research | Grand Rapids Michigan, United States, 49546Deep Blue Retina Clinical Research PLLC | Southaven Mississippi, United States, 38671The Retina Institute | St Louis Missouri, United States, 63128Sierra Eye Associates | Reno Nevada, United States, 89502NJ Retina | Teaneck New Jersey, United States, 07666NJ Retina | Toms River New Jersey, United States, 08755Vision Research Center at Eye Associates of New Mexico | Albuquerque New Mexico, United States, 87109Retina Vitreous Surgeons of CNY, PC | Liverpool New York, United States, 13088Retina Associates of Western NY, PC | Rochester New York, United States, 14620Retina Consultants PLLC | Slingerlands New York, United States, 12159Western Carolina Retinal Associates, PA | Asheville North Carolina, United States, 28803Cape Fear Retinal Associates, PC | Wilmington North Carolina, United States, 28401Piedmont Retina Specialists, P.A. - Winston-Salem Office | Winston-Salem North Carolina, United States, 27103Tulsa Retina Consultant | Tulsa Oklahoma, United States, 74114Verum Research LLC | Eugene Oregon, United States, 97401Erie Retina Research | Erie Pennsylvania, United States, 16507Eye Care Specialists - Kingston Location | Kingston Pennsylvania, United States, 18704Retina Consultants | Charleston South Carolina, United States, 29414Palmetto Retina Center | Florence South Carolina, United States, 29169Retina Consultants of Carolina P.A | Greenville South Carolina, United States, 29605Charles Retina Institute | Germantown Tennessee, United States, 38138Retina Research Institute of Texas Integrated Clinical Research | Abilene Texas, United States, 79606Retina and Vitreous of Texas | Bellaire Texas, United States, 77401Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands | Bellaire Texas, United States, 77401Texas Retina Associates | Dallas Texas, United States, 75231Houston Eye Associates | Houston Texas, United States, 77025Texas Retina Associates | Plano Texas, United States, 75075San Antonio Eye Center | San Antonio Texas, United States, 78215Retinal Consultants of Texas | San Antonio Texas, United States, 78240Retina Consultants of Texas | The Woodlands Texas, United States, 77384Tyler Retina Consultants | Tyler Texas, United States, 75703Strategic Clinical Research Group, LLC | Willow Park Texas, United States, 76087Retina Associates of Utah | Salt Lake City Utah, United States, 84107Salt Lake Retina | West Jordan Utah, United States, 84088The Retina Group of Washington | Fairfax Virginia, United States, 22031Piedmont Eye Center | Lynchburg Virginia, United States, 24502Retina Associates, P.C. | Winchester Virginia, United States, 22601University of Wisconsin School of Medicine and Public Health (UWSMPH) | Madison Wisconsin, United States, 53705