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A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56

NCT06683742

Active Not RecruitingPhase 3

Sponsor: EyePoint Pharmaceuticals, Inc.

Conditions: Wet Age Related Macular Degeneration, wAMD

Interventions: EYP-1901, Aflibercept (2.0 mg)

Countries: United States, Brazil, Czechia, Germany, Hungary, India, Israel, Poland

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

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (113)
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Arcadia, California, United States
  • Beverly Hills, California, United States
  • Encino, California, United States
  • Fullerton, California, United States
  • Glendale, California, United States
  • Huntington Beach, California, United States
  • Long Beach, California, United States
  • Modesto, California, United States
  • Mountain View, California, United States
  • Oakland, California, United States
  • Oxnard, California, United States
  • Redlands, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • Walnut Creek, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Fort Collins, Colorado, United States
  • Lakewood, Colorado, United States
  • Danbury, Connecticut, United States
  • Greenwich, Connecticut, United States
  • Clearwater, Florida, United States
  • Deerfield Beach, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Largo, Florida, United States
  • Palm Beach Gardens, Florida, United States
  • + 83 more on CT.gov