Wet Age Related Macular Degeneration, wAMD
Conditions
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Average change in best corrected visual acuity (BCVA) | Weeks 52 and 56 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of injection burden | Week 56 |
| Average change in best corrected visual acuity (BCVA) | Week 96 |
Countries
Brazil, Czechia, Germany, Hungary, India, Israel, Poland, Slovakia, United Kingdom, United States