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NCT Number: NCT06495918

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Privado de Ojos, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTX-TKI

Drug

Intravitreal Injection of OTX-TKI

aflibercept

Drug

Intravitreal Injection of 2mg of aflibercept

Primary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: Week 48

    Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Collaborators

  • Duke University
  • Fortrea

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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