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

EyePoint Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Wet Age Related Macular Degeneration; wAMD

Treatments: Drug: Aflibercept (2.0 mg); Drug: EYP-1901

Study type: Interventional

Funder types: Industry

Identifiers

NCT06683742

EYP-1901-302

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

400 participants in 2 patient groups

EYP-1901 2686 µg

Experimental group

Description:

EYP-1901

Treatment:

Drug: EYP-1901

Aflibercept

Active Comparator group

Treatment:

Drug: Aflibercept (2.0 mg)