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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

50 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

400 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (76)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

76 locations

Study team and timeline

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Study start

Oct 22, 2024 Actual

Primary completion

Jul 13, 2026 Actual

Study completion

2027-03 Estimated

First posted

Oct 31, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.