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Evaluating a new implant for treating eye disease in older adults

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

Phase 3 Interventional Ocular Therapeutix, Inc. · NCT06495918

This study is testing a new eye implant to see if it can help older adults with a specific type of vision loss improve their sight and reduce fluid leakage.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment825 (estimated)
Ages50 Years and up
SexAll
SponsorOcular Therapeutix, Inc. Industry-sponsored
Drugs / interventionsAxitinib
Locations95 sites (Gilbert, Arizona and 94 other locations)
Trial IDNCT06495918 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of an intravitreal implant containing OTX-TKI (Axitinib) for patients with neovascular age-related macular degeneration (nAMD). The study involves treatment-naïve patients or those who have received limited prior treatment with aflibercept. Participants will receive the implant to assess its effectiveness in reducing leakage and improving vision. The trial aims to determine if this new approach can provide better outcomes compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve individuals with juxtafoveal and/or subfoveal neovascular age-related macular degeneration showing leakage in the study eye.

Not a fit: Patients with significant visual impairment in the fellow eye or those with extensive scarring or atrophy in the study eye may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer improved vision and reduced disease progression for patients with neovascular age-related macular degeneration.

How similar studies have performed: Other studies have shown promise with similar approaches using tyrosine kinase inhibitors, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gilbert, Arizona and 94 other locations

+45 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neovascular Age-related Macular DegenerationNeovascular Age-Related Macular DegenerationTyrosine Kinase InhibitorOTX-TKI
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.