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

NCT06495918 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2025-06-17

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

Intravitreal Injection of OTX-TKI

DRUG

Aflibercept

Intravitreal Injection of 2mg of aflibercept

DRUG

Aflibercept

Intravitreal Injection of 8mg of aflibercept

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Duke University

    collaborator OTHER

  • Ocular Therapeutix, Inc.

    lead INDUSTRY

Principal Investigators

  • Dilsher Dhoot, MD · California Retina Consultants (CRC) - Santa Barbara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2027-01-08
Completion
2027-01-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • 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 NCT06495918 on ClinicalTrials.gov