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New eye implant shows promise for Long-Term wet AMD control

NCT ID NCT07516132

Disease control Sponsor: Ocular Therapeutix, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study is checking the long-term safety of an implant called OTX-TKI (axitinib) for people with wet age-related macular degeneration (AMD). The implant is placed in the eye and slowly releases medicine to control the disease. About 850 people who already completed two years of treatment in earlier studies will be followed for up to three more years. The main goal is to see if the implant remains safe over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
axitinib implant (OTX-TKI)
What this could lead to
If successful, this could show that the axitinib implant is safe for long-term use, potentially offering a treatment that reduces the need for frequent eye injections for wet AMD.
What could go wrong
This is an extension study focused on safety, not on how well the treatment works. It only includes people who already did well in earlier trials, so results may not apply to everyone with wet AMD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96 * Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging * Are able and willing to comply with all study requirements and visits * Have provided written informed consent Exclusion Criteria: * Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1 * History of intraocular inflammation in the study eye * Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular * Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results * Female participants who are pregnant (had a positive urine test at the Baseline visit \[Day 1\]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration (NAMD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Retina Associates

    RECRUITING

    Austin, Texas, 78705, United States

  • California Retina Consultants (CRC)

    RECRUITING

    Bakersfield, California, 93309, United States

  • California Retina Consultants (CRC)

    RECRUITING

    Santa Barbara, California, 93103, United States

  • Cumberland Valley Retina Associates

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Mid Atlantic Retina Specialists

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Palmetto Retina Center

    RECRUITING

    West Columbia, South Carolina, 29619, United States

  • Retina Group of Florida - Fort Lauderdale

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of New England

    RECRUITING

    Waterford, Connecticut, 06385, United States

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