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AzTrials

Neovascular Age-Related Macular DegenerationPhase 3NCT06223958

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

A Phase 3 study testing OTX-TKI (axitinib implant) and Aflibercept in people with Neovascular Age-Related Macular Degeneration, run by Ocular Therapeutix, Inc. at 108 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 years and older
What is being tested?
OTX-TKI (axitinib implant) and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
108 sitesin 3 countries
Study dates
29 Jan 2024to 27 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

108 sites in 3 countries.

108 sites in 3 countries

United States97 sites

  • West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA)

    Abilene, Texas, 79606

  • Palmetto Retina Center

    Aiken, South Carolina, 29802

  • Texas Retina Associates (TRA) - Arlington

    Arlington, Texas, 76012-2505

  • Asheville Eye Associates (AEA) - Retinal Office

    Asheville, North Carolina, 28803

  • Southeast Retina Center, P.C. - Augusta

    Augusta, Georgia, 30909-6440

  • Retina Consultants of Austin PA (RCA) - Central Austin

    Austin, Texas, 78705-1023

  • Austin Retina Associates, PLLC

    Austin, Texas, 78705-1169

  • Keystone Research

    Austin, Texas, 78731

  • Retina Research Center (RRC)

    Austin, Texas, 78750-2302

  • CA CRC California Retina Consultants

    Bakersfield, California, 93103

  • The Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Retina Associates of Cleveland, Inc. - Beachwood

    Beachwood, Ohio, 44122

  • Charleston Neuroscience Institute LLC - Beaufort

    Beaufort, South Carolina, 29902

  • SC CNI Retina Consultants of Charleston

    Beaufort, South Carolina, 29902

  • Retina Consultants of Texas Beaumont

    Beaumont, Texas, 77707

  • Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas)

    Bellaire, Texas, 77401

  • The Retina Center Of New Jersey, LLC - Bloomfield

    Bloomfield, New Jersey, 07003

  • Star Vision Consultants

    Burleson, Texas, 76028

  • IN AVRUC Associated Vitreoretinal and Uveitis Consultants

    Carmel, Indiana, 46290

  • Charleston Neuroscience Institute LLC - Charleston

    Charleston, South Carolina, 29414

  • Pepose Vision Institute

    Chesterfield, Missouri, 63017

  • Illinois Eye and Ear Infirmary at UI Health UIC

    Chicago, Illinois, 60612

  • Illinois Retina Associates, S.C. - Lincoln Park

    Chicago, Illinois, 60657-7227

  • The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC)

    Clearwater, Florida, 33761

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44130

  • Retina Consultants of Southern Colorado - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Speciality Retina Center

    Deerfield Beach, Florida, 33064

  • RSC Research, PLLC

    Denver, Colorado, 80210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Health System - Duke Eye Center Of North Durham

    Durham, North Carolina, 27705

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • The Retina Partners - Encino

    Encino, California, 91436

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • Retina Group of Florida - Fort Lauderdale

    Fort Lauderdale, Florida, 33308-1909

  • Retina Consultants of Orange County - Fullerton

    Fullerton, California, 92835

  • Charles Retina Institute PC

    Germantown, Tennessee, 38138-2405

  • Associated Retina Consultants - Gilbert

    Gilbert, Arizona, 85297

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740-5846

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Long Island Vitreoretinal Consultants (VRC) - Hauppauge

    Hauppauge, New York, 11788

  • Texas Retina Center

    Houston, Texas, 77030

  • Atlantis Eyecare

    Huntington Beach, California, 92647

  • Retina Partners Midwest

    Indianapolis, Indiana, 46290-1166

  • Lakeside Vision Center - Irvine

    Irvine, California, 92604

  • Mississippi Baptist Medical Center

    Jackson, Mississippi, 39202-2064

  • Retina Consultants of Texas - Katy

    Katy, Texas, 77494

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Florida Retina Institute - Lake Mary

    Lake Mary, Florida, 32746-2175

  • Florida Retina Consultants - Lakeland

    Lakeland, Florida, 33805

  • Colorado Retina Associates (CRA) - Lakewood

    Lakewood, Colorado, 80228

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088

  • Retina-Vitreous Associates Medical Group - Los Angeles

    Los Angeles, California, 90017-4886

  • South Florida Retina Institute

    Miami, Florida, 33145

  • CA RCMG Retinal Consultants Medical Group, Inc.

    Modesto, California, 95356

  • Retina Sacramento MSO, LLC

    Modesto, California, 95356

  • Retina Consultants of Charleston - Mount Pleasant

    Mt. Pleasant, South Carolina, 29464

  • Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location

    Nashville, Tennessee, 37203-1596

  • Wagner Macula & Retina Center - Norfolk, VA Office

    Norfolk, Virginia, 23502-3933

  • University Retina and Macula Associates, P.C.

    Oak Forest, Illinois, 60452

  • Kaiser Permanente Division of Research

    Oakland, California, 94611

  • CA CRC California Retina Consultants

    Oxnard, California, 93103

  • Stanford University School of Medicine, Byers Eye Institute

    Palo Alto, California, 94303

  • Doheny Eye Center

    Pasadena, California, 91105

  • AzulVision

    Pasadena, California, 91107

  • Retina Specialty Institute - Pensacola

    Pensacola, Florida, 32503-2030

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona, 85020

  • Retinal Research Institute

    Phoenix, Arizona, 85053

  • Maine Eye Center - Marginal Way Campus

    Portland, Maine, 04101-2438

  • Black Hills Regional Eye Institute (BHREI)

    Rapid City, South Dakota, 57701-7374

  • Sierra Eye Associates

    Reno, Nevada, 89502-1605

  • Vistar Eye Center Vision and Surgery Specialists

    Roanoke, Virginia, 24019

  • Associated Retinal Consultants P.C. (ARC) - Royal Oak

    Royal Oak, Michigan, 48073

  • Retina Associates of Utah, P.C - Intermountain Medical Center Location

    Salt Lake City, Utah, 84107-6767

  • Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location

    San Antonio, Texas, 78240-1502

  • Retinal Consultants of Texas - San Antonio Medical Center

    San Antonio, Texas, 78240

  • TX RCTX Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants (CRC) - Santa Barbara

    Santa Barbara, California, 93103-4211

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

  • NY LIVRC Long Island Vitreoretinal Consultants

    Shirley, New York, 11967

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

  • MedEye Associates - Miami

    South Miami, Florida, 33143

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Retina Research Institute, LLC

    St Louis, Missouri, 63144-1317

  • Retina Vitreous Associates of Florida (RVA) - Saint Petersburg

    St. Petersburg, Florida, 33711-1141

  • Retina Vitreous Associates of Florida - Tampa

    Tampa, Florida, 33607

  • Retina Associates of Florida LLC Tampa MacDill

    Tampa, Florida, 33609

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Macula Retina Vitreous Center

    Torrance, California, 90505

  • Bay Area Retina Associates, A Medical Group

    Walnut Creek, California, 94598

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169-2429

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266-7705

  • Retina Associates of Cleveland, Inc. - Youngstown

    Youngstown, Ohio, 44505

Other trials in United States

Argentina10 sites

  • Centro Oftalmologico Dr. Charles S.A

    Buenos Aires, Buenos Aires F.D., 1121

  • Organizacion Medica de Investigacion OMI

    Buenos Aires, Buenos Aires F.D., C1015

  • Fundacion Zambrano - Cirugia Ocular

    Buenos Aires, Buenos Aires F.D., C1023AAQ

  • Instituto Oftalmologico de Alta Complejidad

    Buenos Aires, Buenos Aires F.D., C1120AAN

  • Centro Privado de Ojos Romagosa SA

    Córdoba, X5000AAI

  • Oftar Mendoza Srl Centro Privado de Oftalmologia

    Mendoza, M5500GGK

  • Centrovision

    Mendoza, M5500

  • Buenos Aires Macula

    Pilar, Buenos Aires, B1629AHJ

  • Oftalmologia Global

    Rosario, Santa Fe Province, S2000

  • Laser Vision Group

    Santa Fe, S2126DTO

Other trials in Argentina

Puerto Rico1 site

  • Emanuelli research and development

    Arecibo, 612

Other trials in Puerto Rico

About this study

Official title: 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

Being tested
OTX-TKI (axitinib implant), Aflibercept
Keywords
Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OTX-TKI (axitinib implant)Drug

    Intravitreal Injection of OTX-TKI (axitinib implant)

  • AfliberceptDrug

    Injection of 2mg (0.05mL) of aflibercept

Study groups in NCT06223958
Study groupRoleWhat they receive
OTX-TKI (axitinib implant)ExperimentalNot described
Receives: Drug: OTX-TKI (axitinib implant)
ControlOtherNot described
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best corrected visual acuity (BCVA)

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

    Measured: Up to 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start29 Jan 2024
  3. Primary completion29 Apr 2026 (estimated)
  4. Study completion27 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223958
Sponsor's protocol ID
OTX-TKI-2023-AMD-301
Other IDs
SOL-1
Status last verified
Apr 2025
First submitted
12 Jan 2024
Last updated
18 Apr 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OTX-TKI (axitinib implant) and Aflibercept in people with Neovascular Age-Related Macular Degeneration, run by Ocular Therapeutix, Inc. at 108 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Argentina, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best corrected visual acuity (BCVA) (time frame: Up to 36 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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