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

April 15, 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 (nAMD)

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 (Actual)

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.
344

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
      • Cordoba, Argentina, X5000AAI
        • Centro Privado de Ojos Romagosa SA
      • Mendoza, Argentina, M5500GGK
        • Oftar Mendoza Srl Centro Privado de Oftalmologia
      • Mendoza, Argentina, M5500
        • Centrovisión
      • Santa Fe, Argentina, S2126DTO
        • Laser Vision Group
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Buenos Aires Mácula
    • Caba
      • Buenos Aires, Caba, Argentina, 1121
        • Centro Oftalmologico Dr. Charles S.A
      • Buenos Aires, Caba, Argentina, C1015
        • Organizacion Medica de Investigacion OMI
      • Buenos Aires, Caba, Argentina, C1023AAQ
        • Fundacion Zambrano - Cirugia Ocular
      • Buenos Aires, Caba, Argentina, C1120AAN
        • Instituto Oftalmologico de Alta Complejidad
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000
        • Oftalmologìa Global
  • Puerto Rico
      • Arecibo, Puerto Rico, 612
        • Emanuelli research and development
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Associated Retina Consultants - Gilbert
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants - Phoenix
      • Scottsdale, Arizona, United States, 85255
        • Retina Macula Institute of Arizona
    • California
      • Bakersfield, California, United States, 93103
        • CA CRC California Retina Consultants
      • Encino, California, United States, 91436
        • The Retina Partners - Encino
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County - Fullerton
      • Huntington Beach, California, United States, 92647
        • Atlantis Eyecare
      • Irvine, California, United States, 92604
        • Lakeside Vision Center - Irvine
      • Los Angeles, California, United States, 90017-4886
        • Retina-Vitreous Associates Medical Group - Los Angeles
      • Modesto, California, United States, 95356
        • CA RCMG Retinal Consultants Medical Group, Inc.
      • Modesto, California, United States, 95356
        • Retina Sacramento MSO, LLC
      • Oakland, California, United States, 94611
        • Kaiser Permanente Division of Research
      • Oxnard, California, United States, 93103
        • CA CRC California Retina Consultants
      • Palo Alto, California, United States, 94303
        • Stanford University School of Medicine, Byers Eye Institute
      • Pasadena, California, United States, 91105
        • Doheny Eye Center
      • Pasadena, California, United States, 91107
        • AzulVision
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, United States, 93103-4211
        • California Retina Consultants (CRC) - Santa Barbara
      • Torrance, California, United States, 90505
        • Macula Retina Vitreous Center
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates, A Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado - Colorado Springs
      • Denver, Colorado, United States, 80210
        • RSC Research, PLLC
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates (CRA) - Lakewood
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England, PC
    • Florida
      • Clearwater, Florida, United States, 33761
        • The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Deerfield Beach, Florida, United States, 33064
        • Speciality Retina Center
      • Fort Lauderdale, Florida, United States, 33308-1909
        • Retina Group of Florida - Fort Lauderdale
      • Lake Mary, Florida, United States, 32746-2175
        • Florida Retina Institute - Lake Mary
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants - Lakeland
      • Miami, Florida, United States, 33145
        • South Florida Retina Institute
      • Pensacola, Florida, United States, 32503-2030
        • Retina Specialty Institute - Pensacola
      • Saint Petersburg, Florida, United States, 33711-1141
        • Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
      • South Miami, Florida, United States, 33143
        • MedEye Associates - Miami
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida LLC Tampa MacDill
      • Tampa, Florida, United States, 33607
        • Retina Vitreous Associates of Florida - Tampa
    • Georgia
      • Augusta, Georgia, United States, 30909-6440
        • Southeast Retina Center, P.C. - Augusta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Illinois Eye and Ear Infirmary at UI Health UIC
      • Chicago, Illinois, United States, 60657-7227
        • Illinois Retina Associates, S.C. - Lincoln Park
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, P.C.
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Indiana
      • Carmel, Indiana, United States, 46290
        • IN AVRUC Associated Vitreoretinal and Uveitis Consultants
      • Indianapolis, Indiana, United States, 46290-1166
        • Retina Partners Midwest
    • Iowa
      • West Des Moines, Iowa, United States, 50266-7705
        • Wolfe Eye Clinic
    • Maine
      • Portland, Maine, United States, 04101-2438
        • Maine Eye Center - Marginal Way Campus
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Wilmer Eye Institute
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740-5846
        • Mid Atlantic Retina Specialists - Hagerstown
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants P.C. (ARC) - Royal Oak
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Retina Consultants of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39202-2064
        • Mississippi Baptist Medical Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pepose Vision Institute
      • Saint Louis, Missouri, United States, 63144-1317
        • Retina Research Institute, LLC
    • Nevada
      • Reno, Nevada, United States, 89502-1605
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • The Retina Center Of New Jersey, LLC - Bloomfield
    • New York
      • Hauppauge, New York, United States, 11788
        • Long Island Vitreoretinal Consultants (VRC) - Hauppauge
      • Liverpool, New York, United States, 13088
        • Retina-Vitreous Surgeons of Central New York
      • Shirley, New York, United States, 11967
        • NY LIVRC Long Island Vitreoretinal Consultants
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Eye Associates (AEA) - Retinal Office
      • Durham, North Carolina, United States, 27705
        • Duke University Health System - Duke Eye Center Of North Durham
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland, Inc. - Beachwood
      • Cleveland, Ohio, United States, 44130
        • Retina Associates of Cleveland
      • Youngstown, Ohio, United States, 44505
        • Retina Associates of Cleveland, Inc. - Youngstown
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research
    • South Carolina
      • Aiken, South Carolina, United States, 29802
        • Palmetto Retina Center
      • Beaufort, South Carolina, United States, 29902
        • Charleston Neuroscience Institute LLC - Beaufort
      • Beaufort, South Carolina, United States, 29902
        • SC CNI Retina Consultants of Charleston
      • Charleston, South Carolina, United States, 29414
        • Charleston Neuroscience Institute LLC - Charleston
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
      • Mount Pleasant, South Carolina, United States, 29464
        • Retina Consultants of Charleston - Mount Pleasant
      • West Columbia, South Carolina, United States, 29169-2429
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701-7374
        • Black Hills Regional Eye Institute (BHREI)
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision
    • Tennessee
      • Germantown, Tennessee, United States, 38138-2405
        • Charles Retina Institute PC
      • Nashville, Tennessee, United States, 37203-1596
        • Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location
    • Texas
      • Abilene, Texas, United States, 79606
        • West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA)
      • Arlington, Texas, United States, 76012-2505
        • Texas Retina Associates (TRA) - Arlington
      • Austin, Texas, United States, 78731
        • Keystone Research
      • Austin, Texas, United States, 78705-1023
        • Retina Consultants of Austin PA (RCA) - Central Austin
      • Austin, Texas, United States, 78705-1169
        • Austin Retina Associates, PLLC
      • Austin, Texas, United States, 78750-2302
        • Retina Research Center (RRC)
      • Beaumont, Texas, United States, 77707
        • Retina Consultants of Texas Beaumont
      • Bellaire, Texas, United States, 77401
        • Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)
      • Burleson, Texas, United States, 76028
        • Star Vision Consultants
      • Houston, Texas, United States, 77030
        • Texas Retina Center
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas - Katy
      • San Antonio, Texas, United States, 78240-1502
        • Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of Texas - San Antonio Medical Center
      • San Antonio, Texas, United States, 78240
        • TX RCTX Retina Consultants of Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
    • Utah
      • Salt Lake City, Utah, United States, 84107-6767
        • Retina Associates of Utah, P.C - Intermountain Medical Center Location
    • Virginia
      • Norfolk, Virginia, United States, 23502-3933
        • Wagner Macula & Retina Center - Norfolk, VA Office
      • Roanoke, Virginia, United States, 24019
        • Vistar Eye Center Vision and Surgery Specialists
    • Wisconsin
      • Wausau, Wisconsin, United States, 54403
        • Eye Clinic of Wisconsin

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 for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.
  • Are at least older than 50 years of age at Day 1.
  • Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA

Exclusion Criteria:

  • Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 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.
Other: Control
Drug: Aflibercept
Injection of 2mg (0.05mL) of aflibercept
Experimental: OTX-TKI (axitinib implant)
Drug: OTX-TKI (axitinib implant)
Intravitreal Injection of OTX-TKI (axitinib implant)

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: Up to 36 Weeks
Maintenance of visual acuity, defined as < 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss
Up to 36 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment emergent adverse events (AEs)
Time Frame: Up to 104 Weeks
Changes Safety Outcomes from Baseline
Up to 104 Weeks

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.
January 29, 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.
April 29, 2026

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.
September 27, 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).
January 12, 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.
January 24, 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.
January 25, 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.
April 18, 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.
April 15, 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.
April 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-301
  • SOL-1 (Other Identifier: Ocular Therapeutix)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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