Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration

Part of paid clinical trials in Bakersfield, California.

Sponsor
Ocular Therapeutix, Inc.
Study ID
NCT04989699
Phase
PHASE1
Status
Completed

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • OTX-TKI/Sham — DRUG
    OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
  • Aflibercept/Sham — DRUG
    Aflibercept administered every 8 weeks

Study Details

Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Key Dates

Start date
Jul 28, 2021
Status verified
Jan 2024
Primary completion
Feb 6, 2023
Completion
Dec 18, 2023

Study Design

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

Arms

  • Active Comparator: OTX-TKI
  • Active Comparator: Aflibercept

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Through study completion, an average of 1 year ]

Locations (6)

FacilityCityStateZIPSite coordinators
Ocular TherapeutixBakersfieldCalifornia93309-
Ocular TherapeutixOxnardCalifornia93036-
Ocular TherapeutixAltamonte SpringsFlorida32701-
Ocular TherapeutixSt. PetersburgFlorida33711-
Ocular TherapeutixRenoNevada89502-
Ocular TherapeutixThe WoodlandsTexas77384-

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