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Refillable eye implant could replace monthly shots for diabetic eye disease

NCT ID NCT04503551

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial tested a small, refillable implant placed in the eye that continuously releases the drug ranibizumab to control diabetic retinopathy. The study enrolled 174 people with moderate-to-severe non-proliferative diabetic retinopathy but without swelling in the center of the retina. The main goal was to see if the implant could improve the severity of retinopathy by at least two steps on a standard scale after one year, compared to standard monthly eye injections.

What this could mean

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

Active substance
ranibizumab
What this could lead to
If successful, this implant could offer a long-lasting way to control diabetic retinopathy, reducing the need for monthly eye injections.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. The implant requires a surgical procedure and carries risks like infection or implant issues.

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

174 people

The number who actually took part.

Started

Aug 2020

Finished

Feb 2026

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 * Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * HbA1c level of ≤12% within 2 months prior to screening or at screening Inclusion Criteria for Study Eye * Moderately severe or severe NPDR (ETDRS-DRSS level 47 or 53) * BCVA score of ≥ 69 letters (20/40 approximate Snellen equivalent or better) Exclusion Criteria: * Uncontrolled blood pressure * Cerebrovascular accident or myocardial infarction within 6 months prior to randomization * Atrial fibrillation diagnosis or worsening within 6 months prior to randomization * Current systemic treatment for a confirmed active systemic infection * Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the study * History 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 patient at high risk for treatment complications in the opinion of the investigator or Sponsor Ocular Exclusion Criteria for Study Eye: * Presence of center-involved diabetic macular edema (defined as CST ≥325 µm) * Any intravitreal anti-VEGF treatment at any time prior to randomization * Any use of medicated intraocular implants, including Ozurdex® or Iluvien® implants at any time prior to randomization * Any intravitreal corticosteroid treatment at any time prior to randomization * Any periocular (e.g., subtenon) corticosteroid treatment at any time prior to randomization * Any PRP at any time prior to randomization * Any macular laser photocoagulation (such as micropulse and focal or grid laser) at any time prior to randomization * Active intraocular inflammation (grade trace or above) * Clinically significant abnormalities of the vitreous-retinal interface involving the macular area or disrupting the macular architecture, such as vitreous-retinal traction or epiretinal membrane (assessed by the investigator and confirmed by the central reading center) * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * Any concurrent ocular condition (e.g., cataract, epiretinal membrane) that would require surgical intervention during the study to prevent or treat visual loss that might result from that condition * Any concurrent ocular condition (e.g., amblyopia, strabismus) that may affect interpretation of study results * History of other ocular diseases that gives reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of study results, or that renders the participant at high risk for treatment complications Ocular Exclusion Criteria for Either Eye * Suspected or active ocular or periocular infection of either eye * Any history uveitis including idiopathic, drug-associated or autoimmune-associated uveitis

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Conditions

The condition(s) this trial relates to.

diabetic retinopathy eye disorder retinal disorder vision disorder

As listed by the trial registrant

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

Diabetic retinopathy

Contacts and locations

Locations

  • 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 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

  • Cape Fear Retinal Associates

    Wilmington, North Carolina, 28401, 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

  • Colorado Clinical Research

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina Consultants;Clinical Research

    Hagerstown, Maryland, 21740, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • Emanuelli Research & Development Center

    Arecibo, 612, Puerto Rico

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324, United States

  • Georgia Retina

    Marietta, Georgia, 30060, 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

  • Kaiser Permanente;RESEARCH AND EVALUATION

    Riverside, California, 92505, United States

  • Maine Eye Center

    Portland, Maine, 04605, United States

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240, United States

  • Mid Atlantic Retina;Retina Research

    Philadelphia, Pennsylvania, 19107, United States

  • New York University (NYU)

    New York, New York, 10012, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Ohio State Havener Eye Institute;Ophthalmology Research

    Columbus, Ohio, 43212, 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 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 Center of Texas

    Grapevine, Texas, 76051, United States

  • Retina Consultants Medical Group

    Sacramento, California, 95841, United States

  • Retina Consultants of Hawaii at Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701, United States

  • Retina Consultants of Orange County;Clinical Research

    Fullerton, California, 92835, United States

  • Retina Consultants of Texas

    Houston, Texas, 77401, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Group of New England

    Waterford, Connecticut, 06385, 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 Specialty Institute

    Pensacola, Florida, 32503, 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

  • 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

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37922, United States

  • Southwest Retina Research Center

    Durango, Colorado, 81303, 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;Research

    Dallas, Texas, 75231, United States

  • The Retina Care Center

    Baltimore, Maryland, 21209, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • University Retina

    Lemont, Illinois, 60439, United States

  • VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota

    Minneapolis, Minnesota, 55435, United States

  • Wagner Kapoor Institute;Opthalmology

    Norfolk, Virginia, 23502, United States

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