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

Running, not enrolling · Phase 3

Conditions studied: Wet Age Related Macular Degeneration, wAMD

In brief

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

Key facts

Study ID

NCT06668064

Run by

EyePoint Pharmaceuticals, Inc.

People needed

400

Starts

2024-10-22

Expected to finish

2027-08-01

Last updated by the study team

2026-08-04

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• 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
• 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
• Retinal Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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