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New eye drug trial hopes to tame Diabetes-Related vision loss

NCT ID NCT07553429

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 7 times

Summary

This study tests a new medicine called BI 3812465 for people with diabetic macular edema, a condition that causes swelling in the center of the eye and can lead to vision loss. The trial has two parts: first, a small group gets low to high doses to check safety, then a larger group is randomly assigned to different doses. Participants receive three injections into the eye over several months and are monitored for side effects and eye health.

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

About 49 people

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

Started

May 2026

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: All participants, study eye: * Center-involved diabetic macular edema (CI-DME) defined as CST ≥320 μm (micrometers) at Screening, as confirmed on spectral-domain optical coherence tomography (SD-OCT) and confirmed by the central reading center (CRC). * Sufficiently clear ocular media, adequate pupillary dilation, and fixation, to permit quality fundus imaging. All participants: * Diagnosis of diabetes mellitus (DM) type 1 or type 2 under regular treatment, with glycated hemoglobin HbA1c \<12%. * Be willing and able to understand the study procedures and the risks involved. * Signed and dated written informed consent in accordance with international council for harmonization - good clinical practices (ICH-GCP) and local legislation prior to admission to the trial and any trial related procedures. * Age ≥18 years (or above legal age according to local legislation) at time of signing the informed consent form (ICF). * Male or female participants * Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control * For men, contraception (condom or complete abstinence) should be used as precaution to prevent pregnancy of a partner and/or exposure of an existing embryo or fetus. Further inclusion criteria apply. Exclusion Criteria: All participants, study eye: * Only one functional eye, even if that eye was otherwise eligible for the study. Fellow eye must have sufficient visual function per the investigator's medical judgment in consultation with the participant, to support the participant's daily functioning. * Evidence of active proliferative diabetic retinopathy (PDR). * Evidence of active retinal neovascularization (NV) clinical exam and/or Ultra-Widefield Color Fundus Photography ((UWF-)CFP) within the early treatment diabetic retinopathy study (ETDRS) 7-field, confirmed by the CRC grading. Potential participants with NV outside of the ETDRS 7-field on ultra-widefield imaging may be included in the trial if this condition, based on the assessment of the investigator, does not require acute treatment. * Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle. * Additional eye disease in the study eye that could compromise trial participation: * Uncontrolled glaucoma or intraocular pressure (IOP) \>24 mmHg despite treatment * History of high myopia \>8 diopters in the study eye * Anterior segment and vitreous abnormalities in the study eye that would preclude adequate detection of intraocular inflammation (IOI) or other pathologies * Ocular conditions which, at discretion of the investigator, might interfere with the outcome of the trial. * Previously received ocular gene therapy or cell therapy. * Corticosteroid use locally or systemically within 1 month prior to Screening. * Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy may be permitted, if performed more than 2 months prior to Day 1. Further exclusion criteria apply.

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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

How to take part

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

  1. The places running it

    29 sites in 2 countries. 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

  • Associated Retina Consultants, Ltd.

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research, LLC

    RECRUITING

    Austin, Texas, 78750, United States

  • Bay Area Retina Associates - Walnut Creek

    RECRUITING

    Walnut Creek, California, 94598, United States

  • California Retina Consultants-Oxnard-70187

    RECRUITING

    Oxnard, California, 93036, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • East Florida Eye Institute

    RECRUITING

    Stuart, Florida, 34994, United States

  • Emanuelli Research & Development Center

    RECRUITING

    Arecibo, 00612, Puerto Rico

  • Emerson Clinical Research Institute

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • EyeHealth Northwest

    RECRUITING

    Portland, Oregon, 97225, United States

  • Florida Retina Consultants

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Global Research Management

    RECRUITING

    Glendale, California, 91204, United States

  • Medical Center Ophthalmology Associates

    RECRUITING

    San Antonio, Texas, 78240, United States

  • North Carolina Retina Associates

    RECRUITING

    Wake Forest, North Carolina, 27587, United States

  • Ophthalmic Consultants of Long Island

    RECRUITING

    Oceanside, New York, 11572, United States

  • Red River Research Partners, LLC

    RECRUITING

    Fargo, North Dakota, 58103, United States

  • Research Network Arizona

    RECRUITING

    Scottsdale, Arizona, 85255, United States

  • Retina Associates of Southern California

    NOT_YET_RECRUITING

    Huntington Beach, California, 92647, United States

  • Retina Consultants of Texas - San Antonio Medical Center

    NOT_YET_RECRUITING

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas-Bellaire-67493

    NOT_YET_RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas-The Woodlands-67575

    NOT_YET_RECRUITING

    The Woodlands, Texas, 77384, United States

  • Retina Group of Florida - Fort Myers Retina Center

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Retina Group of New England, PC

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Retina-Vitreous Associates Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Retinal Consultants Medical Group

    RECRUITING

    Sacramento, California, 95825, United States

  • Strategic Clinical Research Group

    RECRUITING

    Willow Park, Texas, 76087, United States

  • Tennessee Retina

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Valley Retina Institute, PA

    RECRUITING

    McAllen, Texas, 78503, United States

  • Verum Research, LLC

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Win Retina

    RECRUITING

    Arcadia, California, 91006, United States

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