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Could a tiny implant replace monthly eye shots for wet AMD?

NCT ID NCT05769153

Disease control Sponsor: Alcon Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests an experimental implant (AR-14034) that slowly releases medication inside the eye to treat wet age-related macular degeneration (AMD). The goal is to see if it is safe and can work as well as or better than standard anti-VEGF injections, which require frequent doctor visits. About 139 people with wet AMD will receive either the implant or standard injections, and their vision will be tracked for nearly a year.

What this could mean

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

Active substance
AR-14034 sustained-release implant
What this could lead to
If successful, this implant could reduce the need for frequent eye injections for wet AMD, offering longer-lasting treatment with fewer clinic visits.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 139 participants, so safety and effectiveness are not yet proven. The implant may not work as well as current injections or could cause unexpected side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

139 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Sep 2027

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.

Key Inclusion Criteria \[Stage 1 and Stage 2\]: * Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD); * Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye; * BCVA greater than 20 letters (approximately 20/400 Snellen equivalent) in the non-study eye; * Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures; * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; * Other protocol-specified inclusion criteria may apply. \[Stage 1\]: * Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator. \[Stage 2\]: * Treatment-naïve, or diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye. Key Exclusion Criteria \[Stage 1 and Stage 2\]: * History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study; * Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD; * Any active intraocular or periocular infection or active intraocular inflammation; * Treatment with ocular anti-VEGF product in the study eye within 28 days before Week 1 \[Stage 1\] or within 56 days before Screening \[Stage 2\]. * Uncontrolled glaucoma in the study eye; * Uncontrolled blood pressure; * Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study; * Other protocol-specified exclusion criteria may apply.

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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)

Contacts and locations

Locations

  • Associated Retina Consultants - Gilbert

    Gilbert, Arizona, 85297, United States

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research, LLC

    Austin, Texas, 78750, United States

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Austin Retina Associates (San Marcos)

    San Marcos, Texas, 78666, United States

  • Azul Vision Pasadena

    Pasadena, California, 99107, United States

  • Berkeley Eye Center

    Houston, Texas, 77027, United States

  • Carolina Eyecare Physicians LLC

    Mt. Pleasant, South Carolina, 29464, United States

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • Erie Retina Research

    Erie, Pennsylvania, 16507, United States

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • Florida Retina Institute

    Jacksonville, Florida, 32216, United States

  • Florida Retina Institute

    Orlando, Florida, 32806, United States

  • Mid Florida Eye Center

    Mt. Dora, Florida, 32757, United States

  • MidAtlantic Retina Research

    Philadelphia, Pennsylvania, 19107, United States

  • Mississippi Retina Associates

    Madison, Mississippi, 39110, United States

  • NYC Retina - Queens

    Forest Hills, New York, 11375, United States

  • Northern California Retina Vitreous Associates Medical Group

    Mountain View, California, 94040, United States

  • Pacific Northwest Retina

    Burlington, Washington, 98233, United States

  • Retina Associates of Orange County

    Laguna Hills, California, 92653, United States

  • Retina Associates of SW PC

    Tucson, Arizona, 85704, United States

  • Retina Consultants of Carolina

    Greenville, South Carolina, 29605, United States

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80809, United States

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78251, United States

  • Retina Group of New England | Waterford

    Waterford, Connecticut, 06385, United States

  • Retina Research Center of Southern Utah

    St. George, Utah, 84790, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Specialty Institute

    Pensacola, Florida, 32503, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Star Vision Research

    Burleson, Texas, 76028, United States

  • Texas Retina Associates

    Dallas, Texas, 75231, United States

  • Texas Retina Associates - Arlington

    Arlington, Texas, 76012, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • Thomas Eye Group Main Office

    Sandy Springs, Georgia, 30328, United States

  • Trinity Research Group

    Dothan, Alabama, 36301, United States

  • Twin Cities Eye Consultants

    Coon Rapids, Minnesota, 55433, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452, United States

  • Verum Research, LLC

    Eugene, Oregon, 97401, United States

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

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