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

June 16, 2025 updated by: Ocular Therapeutix, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
825

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1015
        • Organizacion Medica de Investigacion (OMI)
      • Buenos Aires, Argentina, C1033AAW
        • Centro Privado de Ojos
      • Caba, Argentina, C1061AAE
        • Buenos Aires Mácula
      • Caba, Argentina, C1120AAN
        • Instituto Oftalmologico de Buenos Aires SA - OFTALMOS
      • Caba, Argentina, S
        • Fundacion Zambrano - Cirugia Ocular
      • Ciudad Autonoma de Buenos Aire, Argentina, C1023AAQ
        • Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares
      • Ciudad Autonoma de Buenos Aires, Argentina, C1121ABB
        • Charles Research Center (Centro Oftalmologico Dr. Charles S.A)
      • Ciudad de Mendoza, Argentina, M5500
        • Centro Vision S.A.
      • Mendoza, Argentina, M5500GGK
        • Oftar Mendoza Srl Centro Privado de Oftalmologia
      • Rosario, Argentina, S2000
        • Laser Vision Group
  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Albury Eye Clinic
      • Parramatta, New South Wales, Australia, 2150
        • Marsden Eye Specialists (MES) - Parramatta
  • Puerto Rico
      • Arecibo, Puerto Rico, 612
        • Emanuelli Research and Development Center, LLC
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Associated Retina Consultant
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants, Ltd.
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute, LLC
      • Scottsdale, Arizona, United States, 85255
        • Retina Macula Institute of Arizona
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Encino, California, United States, 91436
        • The Retina Partners
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • Huntington Beach, California, United States, 92647
        • Atlantis Eyecare
      • Huntington Beach, California, United States, 92647
        • Salehi Retina Institute, Inc., dba Retina Associates of Southern California
      • Oakland, California, United States, 94611
        • Kaiser Permanente Division of Research
      • Oxnard, California, United States, 93036
        • California Retina Consultants
      • Palo Alto, California, United States, 94303
        • Stanford University School of Medicine, Byers Eye Institute
      • Palo Alto, California, United States, 94303
        • Stanford Health Care - Byers Eye Institute
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group, Inc
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
      • Torrance, California, United States, 90503
        • Macula Retina Vitreous Research Institute
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
      • Denver, Colorado, United States, 80210
        • RSC Research, LLC
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates
    • Connecticut
      • Manchester, Connecticut, United States, 06042
        • Retina Consultants, P.C
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Deerfield Beach, Florida, United States, 33064
        • Advanced Research LLC.
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Miami, Florida, United States, 33145
        • South Florida Retina Institute
      • Orlando, Florida, United States, 32806
        • Florida Retina Institude
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida- Saint Petersburg
      • South Miami, Florida, United States, 33143
        • MedEye Associates
      • Tampa, Florida, United States, 33617
        • Retina Vitreous Associates of Florida
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, PC
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic Opthalmology Department
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Associate Vitreoretinal and Uveitis Consultants
      • Carmel, Indiana, United States, 46290
        • Retina Partners Midwest, P.C.
      • Indianapolis, Indiana, United States, 46290
        • Retina Partners Midwest
    • Iowa
      • West Des Moines, Iowa, United States, 50026
        • Wolfe Clinic PC dba Wolfe Eye Clinic
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Retina Group of Washington - Chevy Chase
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists
      • Towson, Maryland, United States, 21204
        • Retina Specialists - Towson Office
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants, P.C.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Retina Consultants of Minnesota
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Mississippi Retina Associates
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center Eye Associates of New Mexico
    • New York
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of CNY, PC
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Eye Associates (AEA) - Asheville
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research
    • South Carolina
      • Aiken, South Carolina, United States, 29802
        • Palmetto Retina Center, LLC
      • Beaufort, South Carolina, United States, 29902
        • Charleston Neuroscience Instititute, LLC
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center, LLC
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center, LLC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute, LLP
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
      • Johnson City, Tennessee, United States, 37604
        • Southeastern Retina Associates PC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina, PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Beaumont, Texas, United States, 77707
        • Retina Consultants of Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Burleson, Texas, United States, 76028
        • Star Vision Research
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Texas Retina Center
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas
      • Southlake, Texas, United States, 76092
        • Retina Center of Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Retina Group of Washington
      • Roanoke, Virginia, United States, 24019
        • Vistar Eye Center
    • Wisconsin
      • Wausau, Wisconsin, United States, 54403
        • Eye Clinic of Wisconsin, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Aflibercept
Intravitreal Injection of 8mg of aflibercept
Other: Aflibercept 8mg high dose
Drug: Aflibercept
Intravitreal Injection of 2mg of aflibercept
Drug: Aflibercept
Intravitreal Injection of 8mg of aflibercept

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity (BCVA)
Time Frame: Week 48
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ocular Therapeutix, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
Fortrea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilsher Dhoot, MD, California Retina Consultants (CRC) - Santa Barbara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OTX-TKI-2023-AMD-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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