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Clinical Trials in the USA / NCT06668064
Active, not recruiting Phase 3

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

NCT06668064 · tracked via the Priya Life Science USA tracker
Sponsor
EyePoint Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-10-22
Last updated
2026-09-03

Condition(s) studied

Wet Age Related Macular DegenerationwAMD

Investigational drug(s) / intervention(s)

EYP-1901Aflibercept (2.0 mg)

EYP-1901: Intravitreal Injection

Aflibercept (2.0 mg): Intravitreal Injection

Study summary

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Eligibility

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (76)

FacilityCityRegionStatus
Retinal Research Institute, LLC Phoenix Arizona
Retina Partners of Northwest Arkansas Springdale Arkansas
California Retina Consultants Bakersfield California
Retina Vitreous Associates Medical Group Beverly Hills California
Macula and Retina Institute Glendale California
Retina Consultants San Diego Poway California
Retina Consultants of Southern California Redlands California
Retinal Consultants Medical Group Sacramento California
Bay Area Retina Associates Walnut Creek California
American Institute of Research Whittier California
RSC Research, PLLC Denver Colorado
Eye Center of Northern Colorado, PC Fort Collins Colorado
Advanced Vision Institute Longmont Colorado
Connecticut Eye Consultants, P.C. Danbury Connecticut
SightSera Clinical Research LLC Greenwich Connecticut
Retina Group of New England, PC Waterford Connecticut
Advanced Research, LLC Deerfield Beach Florida
Florida Retina Consultants Lakeland Florida
Florida Retina Institute Orlando Florida
Retina Specialty Institute Pensacola Florida
Eye Associates of Pinellas Pinellas Park Florida
MedEye Associates South Miami Florida
Retina Specialists of Tampa Tampa Florida
Retina Vitreous Associates of Florida Tampa Florida
Center for Retina & Macular Disease Winter Haven Florida
Gerogia Retina Marietta Georgia
Retina Consultants of Hawaii ‘Aiea Hawaii
Retina Associates Elmhurst Illinois
University Retina and Macula Associates Lemont Illinois
Midwest Eye Institute Carmel Indiana
Retina Associates LLC Lenexa Kansas
Maine Eye Center Portland Maine
The Retina Care Center Baltimore Maryland
Retina Groups of Washington Chevy Chase Maryland
Cumberland Valley Retina Consultants Hagerstown Maryland
Retina Specialists Towson Maryland
Ophthalmic Consultants of Boston OCB - Boston Boston Massachusetts
New England Retina Consultants Springfield Massachusetts
Retina Associates of Michigan Grand Blanc Michigan
Foundation for Vision Research Grand Rapids Michigan

+ 36 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06668064 on ClinicalTrials.gov ↗ ← All trials in the USA