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Active Not Recruiting
NCT06683742
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
Conditions: Wet Age Related Macular Degeneration, wAMD
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 400
Sponsor: EyePoint Pharmaceuticals, Inc.
Location: Associated Retina Consultans Gilbert Arizona
Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
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 \
Source: ClinicalTrials.gov (NCT06683742). StuddyBuddy aggregates publicly available trial information.