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Purpose

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

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OTX-TKI Re-dose
  • Drug: OTX-TKI
    Intravitreal Injection of OTX-TKI
Active Comparator
Aflibercept 2mg on label
  • Drug: Aflibercept
    Intravitreal Injection of 2mg of aflibercept
Other
Aflibercept 8mg high dose
  • Drug: Aflibercept
    Intravitreal Injection of 8mg of aflibercept

Recruiting Locations

More Details

NCT ID
NCT06495918
Status
Active, not recruiting
Sponsor
Ocular Therapeutix, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center