Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: EYP-1901 2060 ug
EYP-1901 2060 ug, single dose
|Experimental: EYP-1901 3090 ug
EYP-1901 3090 ug, single dose
|Active Comparator: Aflibercept
Aflibercept 2 mg [0.05mL] every 8 weeks
Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Primary Outcome Measures
- Average change in best corrected visual acuity (BCVA) [Week 28 and Week 32]
Secondary Outcome Measures
- Change in best corrected visual acuity (BCVA) [Baseline, Week 56]
- Mean change in central retinal thickness on optical coherence tomography (OCT) [Baseline, Week 56]
- Number of rescue injections [Week 56]
Documented diagnosis of wAMD in the study eye, with disease onset within 9 months prior to the Screening Visit.
Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, or aflibercept) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 80 letters (20/25 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.
Central subfield thickness (CST) > 400 µm in the study eye at the Screening Visit or Day 1.
Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma).
Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.
Contacts and Locations
|1||EyePoint Investigative Site||Melbourne||Florida||United States||32901|
|2||EyePoint Investigative Sites||Austin||Texas||United States||78705|
|3||EyePoint Investigative site||Dallas||Texas||United States||75231|
|4||EyePoint Investigative Sites||Houston||Texas||United States||77025|
|5||EyePoint Investigative Site||San Antonio||Texas||United States||78247|
Sponsors and Collaborators
- EyePoint Pharmaceuticals, Inc.
Study Documents (Full-Text)None provided.