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

Sponsor
EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05381948
Collaborator
(none)
150
5
3
16.1
30
1.9

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:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EyePoint Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05381948
    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:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by EyePoint Pharmaceuticals, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022