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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 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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06683742
Acronym
wAMD
Enrollment
400
Registered
2024-11-12
Start date
2024-11-27
Completion date
2027-10-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age Related Macular Degeneration, wAMD

Keywords

Wet Age-related Macular Degeneration, Tyrosine Kinase Inhibitor, EYP-1901, EyePoint

Brief summary

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

Interventions

Intravitreal Injection

Intravitreal Injection

Sponsors

EyePoint Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Average change in best corrected visual acuity (BCVA)Weeks 52 and 56

Secondary

MeasureTime frame
Rate of injection burdenWeek 56
Average change in best corrected visual acuity (BCVA)Week 96

Countries

Brazil, Czechia, Germany, Hungary, India, Israel, Poland, Slovakia, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026