Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

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
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
150 participants
Intervention Model:
Parallel Assignment
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Official Title:
A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
Actual Study Start Date :
Jul 28, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: EYP-1901 2060 ug

EYP-1901 2060 ug, single dose

Drug: Eyp-1901
Intravitreal Injection

Experimental: EYP-1901 3090 ug

EYP-1901 3090 ug, single dose

Drug: Eyp-1901
Intravitreal Injection

Active Comparator: Aflibercept

Aflibercept 2 mg [0.05mL] every 8 weeks

Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Intravitreal Injection
Other Names:
  • Eylea
  • Outcome Measures

    Primary Outcome Measures

    1. Average change in best corrected visual acuity (BCVA) [Week 28 and Week 32]

    Secondary Outcome Measures

    1. Change in best corrected visual acuity (BCVA) [Baseline, Week 56]

    2. Mean change in central retinal thickness on optical coherence tomography (OCT) [Baseline, Week 56]

    3. Number of rescue injections [Week 56]

    Eligibility Criteria


    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • Central subfield thickness (CST) > 400 ┬Ám 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


    Site City State Country Postal Code
    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.


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    EyePoint Pharmaceuticals, Inc. Identifier:
    Other Study ID Numbers:
    • EYP-1901-201
    First Posted:
    May 19, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by EyePoint Pharmaceuticals, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022