NCT06668064Active, not recruitingPhase 3
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
EyePoint Pharmaceuticals, Inc.76 sites in 1 country400 target enrollmentStarted: October 22, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 400
- Locations
- 76
- Primary Endpoint
- Average change in best corrected visual acuity (BCVA)
Study Overview
Brief Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Aflibercept
Active Comparator
Intervention: Aflibercept (2.0 mg) (Drug)
EYP-1901 2686 µg
Experimental
EYP-1901
Intervention: EYP-1901 (Drug)
Outcomes
Primary Outcomes
Average change in best corrected visual acuity (BCVA)
Time Frame: Weeks 52 and 56
Secondary Outcomes
- Rate of injection burden(Week 56)
- Average change in best corrected visual acuity (BCVA)(Week 96)
Investigators
Study Sites (76)
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