First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
EyePoint Pharmaceuticals, Inc.
Study ID
NCT04747197
Phase
PHASE1
Status
Completed

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)

Key Dates

Start date
Jan 20, 2021
Status verified
Jun 2023
Primary completion
May 11, 2022
Completion
May 11, 2022

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 440 ug, single dose
    EYP-1901 440 ug, single dose
  • Experimental: 2060 ug, single dose
    EYP-1901 2060 ug, single dose
  • Experimental: 3090 ug, single dose
    EYP-1901 3090 ug, single dose

Primary Outcome Measure

Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs) [ Time Frame: Week 48 ]

Locations (11)

FacilityCityStateZIPSite coordinators
EyePoint Investigational SitePhoenixArizona85053-
EyePoint Investigational SiteBeverly HillsCalifornia90211-
EyePoint Investigative SiteMountain ViewCalifornia94040-
EyePoint Investigational SiteOxnardCalifornia93036-
EyePoint Investigational SiteMelbourneFlorida32901-
EyePoint Investigational SiteSt. PetersburgFlorida33711-
EyePoint Investigational SiteSpringfieldMassachusetts01107-
EyePoint Investigative SiteAshevilleNorth Carolina28803-
EyePoint Investigational SitePhiladelphiaPennsylvania19107-
EyePoint Investigational SiteAbileneTexas79606-
EyePoint Investigational SiteAustinTexas78705-

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EyePoint Investigational Site· Phoenix, AZEyePoint Investigational Site· Beverly Hills, CAEyePoint Investigative Site· Mountain View, CAEyePoint Investigational Site· Oxnard, CAEyePoint Investigational Site· Melbourne, FLEyePoint Investigational Site· St. Petersburg, FL

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