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

NCT06223958 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2025-04-18

No results posted yet for this study

Summary

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

Conditions

  • Neovascular Age-Related Macular Degeneration

Interventions

DRUG

OTX-TKI (axitinib implant)

Intravitreal Injection of OTX-TKI (axitinib implant)

DRUG

Aflibercept

Injection of 2mg (0.05mL) of aflibercept

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Duke University

    collaborator OTHER

  • Ocular Therapeutix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-04-29
Completion
2027-09-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223958 on ClinicalTrials.gov