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Eye implant could replace monthly shots for diabetes-related vision loss

NCT ID NCT04108156

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a small, refillable implant placed in the eye that delivers medication every 24 weeks, compared to standard monthly eye injections. It includes about 634 adults with diabetic macular edema, a condition that causes vision loss. The goal is to see if the implant works as well as monthly shots while reducing the number of treatments needed.

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

672 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Jul 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

18 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: * Age ≥18 years at time of signing informed consent form (ICF) * Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening Study eye * Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening * BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent) Exclusion Criteria: * High-risk PDR * Active intraocular inflammation (grade trace or above) * Suspected or active ocular or periocular infection of either eye * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study * Cerebrovascular accident or myocardial infarction within 6 months prior to randomization * Atrial fibrillation diagnosis or worsening within 6 months prior to randomization * Uncontrolled blood pressure Substudy: Inclusion Criteria: * Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study * Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center Exclusion Criteria (Cohort 1 Only): * Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications * Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer * Current systemic treatment for a confirmed active systemic infection * Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment * Use of antimitotic or antimetabolite therapy within 30 days Ocular Exclusion Criteria for Study Eye: * Any ocular condition that may render the participant at high risk for surgical or treatment complications * Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit * Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit * Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss * Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant * Ongoing ocular complications that might affect participant safety Ocular Exclusion Criteria for Either Eye * Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis) * Any history of uveitis * Active blepharitis

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

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

Diabetic macular edema

Contacts and locations

Locations

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016, United States

  • Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research

    Asheville, North Carolina, 28803, United States

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • Associated Retinal Consultants - Royal Oak

    Royal Oak, Michigan, 48073, United States

  • Austin Clinical Research, LLC

    Austin, Texas, 78750, United States

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Austin Retina Associates;Opthalmology

    Austin, Texas, 78705, United States

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206, United States

  • California Eye Specialists Medical Group

    Pasadena, California, 91107, United States

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • California Retina Consultants;Research Department

    Santa Barbara, California, 93103, United States

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464, United States

  • Charles Retina Institution;Retina surgery

    Germantown, Tennessee, 38138, United States

  • Charleston Neuroscience

    Ladson, South Carolina, 29456, United States

  • Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina

    Charlotte, North Carolina, 28210, United States

  • Cincinnati Eye Institute;Retina

    Cincinnati, Ohio, 45242, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Clinical Research

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina Consultants;Clinical Research

    Hagerstown, Maryland, 21740, United States

  • Doheny Eye Institute

    Pasadena, California, 91105, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • East Bay Retina Consultants

    Oakland, California, 94609, United States

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Eye Center of Northern Colorado

    Fort Collins, Colorado, 80528, United States

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324, United States

  • Georgia Retina

    Marietta, Georgia, 30060, United States

  • Graystone Eye;Clinical Research

    Hickory, North Carolina, 28602, United States

  • Illinois Retina Associates

    Joliet, Illinois, 60435, United States

  • Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst

    Baltimore, Maryland, 21287, United States

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095, United States

  • Long Island Vitreoretinal Consultants;Opthalmology

    Great Neck, New York, 11021, United States

  • Maine Eye Center

    Portland, Maine, 04605, United States

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240, United States

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107, United States

  • Midwest Retina;Retina/Vitreous

    Dublin, Ohio, 43016, United States

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912, United States

  • New York University (NYU)

    New York, New York, 10017, United States

  • Northern California Retina-Vitreous Associates

    Mountain View, California, 94040, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Ohio State Havener Eye Institute;Ophthalmology Research

    Columbus, Ohio, 43212, United States

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572, United States

  • Orange County Retina Medical Group

    Santa Ana, California, 92705, United States

  • Pacific Northwest Retina

    Silverdale, Washington, 98383, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Pepose Vision Institute

    Chesterfield, Missouri, 63017, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Retina & Vitreous Associates of Kentucky

    Lexington, Kentucky, 40509, United States

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401, United States

  • Retina Associates

    Lenexa, Kansas, 66215, United States

  • Retina Associates of Florida;Retina Associates of Florida

    Tampa, Florida, 33609, United States

  • Retina Associates of New Jersey

    Teaneck, New Jersey, 07666, United States

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Retina Consultants Medical Group

    Sacramento, California, 95841, United States

  • Retina Consultants of Orange County;Clinical Research

    Fullerton, California, 92835, United States

  • Retina Consultants of Texas

    Houston, Texas, 77401, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of New England

    Waterford, Connecticut, 06385, United States

  • Retina Institute

    St Louis, Missouri, 63128, United States

  • Retina Institute of Virginia

    Richmond, Virginia, 23235, United States

  • Retina Northwest;Research Department

    Portland, Oregon, 97221, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Specialist

    Towson, Maryland, 21204, United States

  • Retina Specialists Of Michigan

    Grand Rapids, Michigan, 49546, United States

  • Retina Specialty Institute

    Pensacola, Florida, 32503, United States

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711, United States

  • Retina Vitreous Center - Glen Eagles

    Edmond, Oklahoma, 73013, United States

  • Retina Vitreous Surgeons of Central New York

    Liverpool, New York, 13088, United States

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retinal Consultants of Arizona;Opthalmology

    Phoenix, Arizona, 85014, United States

  • Rocky Mountain Retina Consultants

    Murray, Utah, 84107, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southern Vitreoretinal Associates;Research

    Tallahassee, Florida, 32308, United States

  • Spokane Eye Clinical Research;Spokane Eye Surgery Center

    Spokane, Washington, 99204, United States

  • Tennessee Retina

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates

    Arlington, Texas, 76012, United States

  • Texas Retina Associates

    Fort Worth, Texas, 76104, United States

  • Texas Retina Associates;Research

    Dallas, Texas, 75231, United States

  • The Retina Group of Washington;Retinal Disease

    Chevy Chase, Maryland, 20815, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University Retina

    Lemont, Illinois, 60439, United States

  • Vitreo Retinal Associates

    Worcester, Massachusetts, 01605, United States

  • VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota

    Minneapolis, Minnesota, 55435, United States

  • Wagner Kapoor Institute;Opthalmology

    Norfolk, Virginia, 23502, United States

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266, United States

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.