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

NCT No.: NCT06495918

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

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 juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
  • Have provided written consent

Exclusion Criteria
  • Monocular subject or Best Corrected Visual Acuity (BCVA) score of \<20 ETDRS letters or 20/400 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
  • OTX-TKI
  • Tyrosine Kinase Inhibitor
  • Neovascular Age-Related Macular Degeneration

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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