Active, currently enrolling

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)

NCT No.: NCT06223958

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

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)

Purpose

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

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Keywords and/or Specific Medical Conditions

  • Ophthalmology

Sponsors

  • Ocular Therapeutix, Inc.

KP Clinical Facility

Clinical Area

  • Ophthalmology

Principal Investigator

Robin Vora  

Contact Information

 - CTP Collaborate Team
- ctpcollaborate@kp.org
- All Kaiser Permanente Northern California Medical Centers

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