A 2-year Study of EYP-1901 in Subjects with Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will Be Determined At Week 52
Phase 3
Recruiting
- Conditions
- Wet Age Related Macular Degeneration
- Interventions
- Drug: EYP-1901Drug: Aflibercept (2.0 mg)
- Registration Number
- NCT06683742
- Lead Sponsor
- EyePoint Pharmaceuticals, Inc.
- Brief Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
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.
Read More
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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EYP-1901 2686 µg EYP-1901 EYP-1901 Aflibercept Aflibercept (2.0 mg) -
- Primary Outcome Measures
Name Time Method Average change in best corrected visual acuity (BCVA) Weeks 52 and 56
- Secondary Outcome Measures
Name Time Method Rate of injection burden Week 56 Average change in best corrected visual acuity (BCVA) Week 96
Trial Locations
- Locations (1)
LUCIA Study Site
🇺🇸Hagerstown, Maryland, United States
Related News
EyePoint begins dosing in second global Phase 3 LUCIA clinical trial of Duravyu for the ...
EyePoint Pharmaceuticals initiated the LUCIA trial, its second global Phase 3 study of Duravyu for wet AMD. Duravyu, a sustained-release therapy delivering vorolanib via a bioerodible Durasert E formulation, aims to offer long-term management of wet AMD. The LUCIA trial includes treatment-naïve and previously treated patients, with re-dosing every 6 months. The LUGANO and LUCIA trials, comparing Duravyu to aflibercept, aim to enroll 400 patients each worldwide, assessing efficacy, safety, and dosing flexibility.
EyePoint Announces First Patient Dosed in Second Global Phase 3 LUCIA Clinical Trial of ...
EyePoint Pharmaceuticals announces first patient dosed in LUCIA trial, its second global Phase 3 clinical trial of DURAVYU for wet AMD. DURAVYU, a sustained delivery therapy, aims to improve treatment for serious retinal diseases. The trial is part of a robust clinical dataset for long-acting treatments in wet AMD, positioning EyePoint as a leader in sustained-release ocular drug delivery.
EyePoint doses first patient in second global Phase 3 LUCIA clinical trial of Duravyu for the ...
EyePoint Pharmaceuticals initiates LUCIA trial, its second global Phase 3 study of Duravyu for wet AMD, featuring a sustained-release therapy with vorolanib delivered via Durasert E. The trial aims to assess efficacy, safety, and dosing flexibility, with re-dosing every 6 months, targeting both treatment-naïve and previously treated patients.
- Prev
- 1
- Next