Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
EyePoint Pharmaceuticals, Inc.
Study ID
NCT05383209
Phase
PHASE2
Status
Completed

Conditions

  • Nonproliferative Diabetic Retinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EYP-1901 — DRUG
    EYP-1901 will be administered to the study eye by a single injection through the pars plana using a pre-loaded applicator with a 22-gauge needle. Each EYP-1901 IVT insert has been designed to deliver vorolanib into the vitreous humor for approximately 6 to 9 months.
  • Sham IVT — OTHER
    Sham injections will be used to maintain masking of investigational EYP-1901 therapy for study subjects.

Study Details

A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.

Key Dates

Start date
Sep 28, 2022
Status verified
Aug 2025
Primary completion
Feb 12, 2024
Completion
May 6, 2024

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EYP-1901 2060 ug
    EYP-1901 2060 ug; single injection
  • Experimental: EYP-1901 3090 ug
    EYP-1901 3090 ug; single injection
  • Sham Comparator: Sham IVT
    Sham IVT; single injection

Primary Outcome Measure

Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36 [ Time Frame: Baseline (Day 1) and Week 36 ]

Locations (36)

FacilityCityStateZIPSite coordinators
EyePoint Investigative SitePhoenixArizona85020-
EyePoint Investigative SiteHuntington BeachCalifornia92647-
EyePoint Investigative SiteOxnardCalifornia93036-
EyePoint Investigative SitePalm DesertCalifornia92211-
EyePoint Investigative SitePasadenaCalifornia90041-
EyePoint Investigative SitePowayCalifornia92064-
EyePoint Investigative SiteSacramentoCalifornia95825-
EyePoint Investigative SiteDanburyConnecticut06810-
EyePoint Investigative SiteClearwaterFlorida33761-
EyePoint Investigative SiteMelbourneFlorida32901-
EyePoint Investigative SiteMiamiFlorida33143-
EyePoint Investigative SiteWinter HavenFlorida33880-
EyePoint Investigative SiteLemontIllinois60439-
EyePoint Investigative SiteIndianapolisIndiana46290-
EyePoint Investigative SiteLenexaKansas66215-
EyePoint Investigative SiteBaltimoreMaryland21209-
EyePoint Investigative SiteHagerstownMaryland21740-
EyePoint Investigative SiteSpringfieldMassachusetts01107-
EyePoint Investigative SiteRenoNevada89502-
EyePoint Investigative SiteBloomfieldNew Jersey07003-
EyePoint Investigative SiteToms RiverNew Jersey08755-
EyePoint Investigative SiteGreat NeckNew York11021-
EyePoint Investigative SiteEriePennsylvania16501-
EyePoint Investigative SiteFlorenceSouth Carolina29501-
EyePoint Investigative SiteLadsonSouth Carolina29456-
EyePoint Investigative SiteRapid CitySouth Dakota57701-
EyePoint Investigative SiteGermantownTennessee38138-
EyePoint Investigative SiteAbileneTexas79606-
EyePoint Investigative SiteAustinTexas78705-
EyePoint Investigative SiteHoustonTexas78240-
EyePoint Investigative SiteMcAllenTexas78503-
EyePoint Investigative SitePlanoTexas75075-
EyePoint Investigative SiteSan AntonioTexas78247-
EyePoint Investigative SiteThe WoodlandsTexas77384-
EyePoint Investigative SiteLynchburgVirginia24502-
EyePoint Investigative SiteBellevueWashington98004-

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