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Neovascular Age-related Macular DegenerationPhase 3NCT06495918

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

A Phase 3 study testing OTX-TKI and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Ocular Therapeutix, Inc. at 97 sites in 4 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 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
825 participants
Where
97 sitesin 4 countries
Study dates
27 Nov 2024to 8 Jan 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 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

Who cannot join

  • 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.

Trial locations and contacts

97 sites in 4 countries.

97 sites in 4 countries

United States84 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Palmetto Retina Center, LLC

    Aiken, South Carolina, 29802

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Asheville Eye Associates (AEA) - Asheville

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Charleston Neuroscience Instititute, LLC

    Beaufort, South Carolina, 29902

  • Retina Consultants of Texas

    Beaumont, Texas, 77707

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

  • Star Vision Research

    Burleson, Texas, 76028

  • Associate Vitreoretinal and Uveitis Consultants

    Carmel, Indiana, 46032

  • Retina Partners Midwest, P.C.

    Carmel, Indiana, 46290

  • The Retina Group of Washington - Chevy Chase

    Chevy Chase, Maryland, 20815

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Advanced Research LLC.

    Deerfield Beach, Florida, 33064

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • RSC Research, LLC

    Denver, Colorado, 80210

  • The Retina Partners

    Encino, California, 91436

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Retina Group of Washington

    Fairfax, Virginia, 22031

  • Palmetto Retina Center, LLC

    Florence, South Carolina, 29501

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Associated Retina Consultant

    Gilbert, Arizona, 85297

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

  • Texas Retina Center

    Houston, Texas, 77030

  • Atlantis Eyecare

    Huntington Beach, California, 92647

  • Salehi Retina Institute, Inc., dba Retina Associates of Southern California

    Huntington Beach, California, 92647

  • Retina Partners Midwest

    Indianapolis, Indiana, 46290

  • Southeastern Retina Associates PC

    Johnson City, Tennessee, 37604

  • Retina Consultants of Texas

    Katy, Texas, 77494

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Colorado Retina Associates

    Lakewood, Colorado, 80228

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York, 13088

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

  • Retina Consultants, P.C

    Manchester, Connecticut, 06042

  • South Florida Retina Institute

    Miami, Florida, 33145

  • Retina Consultants of Minnesota

    Minneapolis, Minnesota, 55435

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • Kaiser Permanente Division of Research

    Oakland, California, 94611

  • Florida Retina Institude

    Orlando, Florida, 32806

  • California Retina Consultants

    Oxnard, California, 93036

  • Stanford Health Care - Byers Eye Institute

    Palo Alto, California, 94303

  • Stanford University School of Medicine, Byers Eye Institute

    Palo Alto, California, 94303

  • California Eye Specialists Medical Group, INC

    Pasadena, California, 91107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona, 85020

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053

  • EyeHealth Northwest

    Portland, Oregon, 97225

  • Black Hills Regional Eye Institute, LLP

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Vistar Eye Center

    Roanoke, Virginia, 24019

  • Associated Retinal Consultants, P.C.

    Royal Oak, Michigan, 48073

  • Retinal Consultants Medical Group

    Sacramento, California, 95841

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

  • MedEye Associates

    South Miami, Florida, 33143

  • Retina Center of Texas

    Southlake, Texas, 76092

  • Springfield Clinic Opthalmology Department

    Springfield, Illinois, 62703

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Vitreous Associates of Florida- Saint Petersburg

    St. Petersburg, Florida, 33711

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Macula Retina Vitreous Research Institute

    Torrance, California, 90503

  • Retina Specialists - Towson Office

    Towson, Maryland, 21204

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Eye Clinic of Wisconsin, SC

    Wausau, Wisconsin, 54403

  • Palmetto Retina Center, LLC

    West Columbia, South Carolina, 29169

  • Wolfe Clinic PC dba Wolfe Eye Clinic

    West Des Moines, Iowa, 50026

Other trials in United States

Argentina10 sites

  • Organización Médica de Investigación (OMI)

    Buenos Aires, 1015

  • Centro Privado de Ojos

    Buenos Aires, C1033AAW

  • Charles Research Center (Centro Oftalmologico Dr. Charles S.A)

    Buenos Aires, C1121ABB

  • Buenos Aires Macula

    Caba, C1061AAE

  • Instituto Oftalmologico de Buenos Aires SA - OFTALMOS

    Caba, C1120AAN

  • Fundacion Zambrano - Cirugia Ocular

    Caba, S

  • Fundacion Jorge Zambrano para la investigacion, Diagnostico y Tratamiento de las enfermedades oculares

    Ciudad Autonoma de Buenos Aire, C1023AAQ

  • Oftar Mendoza Srl Centro Privado de Oftalmologia

    Mendoza, M5500GGK

  • Centro Vision S.A.

    Mendoza, M5500

  • Laser Vision Group

    Rosario, S2000

Other trials in Argentina

Australia2 sites

  • Albury Eye Clinic

    Albury, New South Wales, 2640

  • Marsden Eye Specialists (MES) - Parramatta

    Parramatta, New South Wales, 2150

Other trials in Australia

Puerto Rico1 site

  • Emanuelli Research and Development Center, LLC

    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

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, 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-TKIDrug

    Intravitreal Injection of OTX-TKI

  • AfliberceptDrug

    Intravitreal Injection of 2mg of aflibercept

  • AfliberceptDrug

    Intravitreal Injection of 8mg of aflibercept

Study groups in NCT06495918
Study groupRoleWhat they receive
OTX-TKI Re-doseExperimentalNot described
Receives: Drug: OTX-TKI
Aflibercept 2mg on labelActive comparatorNot described
Receives: Drug: Aflibercept
Aflibercept 8mg high doseOtherNot 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)

    Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48

    Measured: Week 48

Timeline

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

  1. First posted11 Jul 2024
  2. Study start27 Nov 2024
  3. Primary completion8 Jan 2027 (estimated)
  4. Study completion8 Jan 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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
825 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06495918
Sponsor's protocol ID
OTX-TKI-2023-AMD-303
Status last verified
Jun 2025
First submitted
3 Jul 2024
Last updated
17 Jun 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OTX-TKI and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Ocular Therapeutix, Inc. at 97 sites in 4 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 2 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Argentina, Australia, 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: Week 48). 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 NCT06495918.

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 17 Jun 2025.

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Clinical Trial NCT06495918 | AzTrials