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
Purpose
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Conditions
- Wet Age Related Macular Degeneration
- wAMD
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental EYP-1901 2686 µg |
EYP-1901 |
|
|
Active Comparator Aflibercept |
|
Recruiting Locations
More Details
- NCT ID
- NCT06683742
- Status
- Active, not recruiting
- Sponsor
- EyePoint Pharmaceuticals, Inc.