A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) P… (NCT06683742) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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
United States400 participantsStarted 2024-11-27
Plain-language summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Average change in best corrected visual acuity (BCVA)