A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 52

Description

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

Conditions

Wet Age Related Macular Degeneration, wAMD

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Study Overview

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Study Details

Study overview

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

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

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 52

Condition
Wet Age Related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Dallas

LUGANO Study Site, Dallas, Texas, United States, 75231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Subfoveal fibrosis, atrophy, or scarring in the center subfield.
  • * BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

EyePoint Pharmaceuticals, Inc.,

Study Record Dates

2027-08