This study is in progress, not accepting new patients

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

a study on Macular Degeneration

Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Michael S. Ip, MD (ucla)
Headshot of Michael S. Ip
Michael S. Ip

Description

Summary

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration

Official Title

A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Keywords

Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI, Macular Degeneration, Wet Macular Degeneration, Aflibercept, Axitinib, OTX-TKI (axitinib implant)

Eligibility

You can join if…

Open to people ages 50 years and up

  • Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.
  • Are at least older than 50 years of age at Day 1.
  • Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA

You CAN'T join if...

  • Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening.
  • Have evidence of a scar, fibrosis, or atrophy of > 50% of the total lesion in the study eye.

Locations

  • Lakeside Vision Center - Irvine
    Irvine California 92604 United States
  • The Retina Partners - Encino
    Encino California 91436 United States
  • Orange County Retina Medical Group
    Santa Ana California 92705 United States
  • Atlantis Eyecare
    Huntington Beach California 92647 United States
  • Retina-Vitreous Associates Medical Group - Los Angeles
    Los Angeles California 90017-4886 United States
  • Kaiser Permanente Division of Research
    Oakland California 94611 United States
  • Doheny Eye Center
    Pasadena California 91105 United States
  • Macula Retina Vitreous Center
    Torrance California 90505 United States
  • Retina Consultants of Orange County - Fullerton
    Fullerton California 92835 United States
  • AzulVision
    Pasadena California 91107 United States

Lead Scientist at University of California Health

  • Michael S. Ip, MD (ucla)
    Dr. Michael S. Ip holds the Gavin S. Herbert Endowed Chair for Macular Degeneration.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ocular Therapeutix, Inc.
ID
NCT06223958
Phase
Phase 3 Macular Degeneration Research Study
Study Type
Interventional
Participants
About 344 people participating
Last Updated