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Could a daily pill replace eye injections for diabetic macular edema?

NCT ID NCT06962839

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an oral medication called BI 1815368 in 300 adults with center-involved diabetic macular edema, a common cause of vision loss in diabetes. Participants take tablets twice daily for about 11 months, and doctors compare vision changes between those on the drug and those on placebo. The goal is to see if the pill can improve eyesight and find the best dose.

What this could mean

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

Active substance
BI 1815368 (oral tablet)
What this could lead to
If it works, this could provide a convenient oral treatment option for diabetic macular edema, potentially reducing the need for frequent eye injections.
What could go wrong
This is an early Phase 2 trial with a placebo group, so the drug may not improve vision or could cause side effects. Results may not apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

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

Started

Jun 2025

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

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: * ≥18 years of age * Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \<12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline * Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm in the study eye at screening * Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply. Exclusion criteria: * Macular edema considered to be due to other causes than CI-DME in the study eye * Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye * Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8mg), and within 6 months before Day 1 for faricimab or aflibercept 8 mg, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye * Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1) * Active ocular inflammation of any history of intraocular inflammation within 1 year * Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if 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 Macular Edema macular retinal edema

As listed by the trial registrant

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

Macular edema

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    97 sites in 9 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Advanced Research Institute

    RECRUITING

    Pompano Beach, Florida, 33064, United States

  • Arizona Retina & Vitreous Research, Central Phoenix

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Asahikawa Medical University Hospital

    RECRUITING

    Asahikawa-shi, 078-8510, Japan

  • Associated Vitreoretinal and Uveitis Consultants

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Augenzentrum am St. Franziskus-Hospital Münster

    RECRUITING

    Münster, 48145, Germany

  • Austin Clinical Research, LLC

    RECRUITING

    Austin, Texas, 78750, United States

  • Austin Research Center for Retina, PLLC

    RECRUITING

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    RECRUITING

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    NOT_YET_RECRUITING

    Austin, Texas, 78705, United States

  • Axon Clinical s.r.o.

    RECRUITING

    Prague, 150 00, Czechia

    Contact Email: •••••@•••••

  • Budapest Retina Associations Kft.

    RECRUITING

    Budapest, 1133, Hungary

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    RECRUITING

    Budapest, 1106, Hungary

  • Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    NOT_YET_RECRUITING

    Budapest, 1204, Hungary

  • Caminomed Sp. z o.o.

    RECRUITING

    Tarnowskie Góry, 42-600, Poland

  • Center for Retina and Macular Disease

    RECRUITING

    Winter Haven, Florida, 33880, United States

  • Central Hospital of Northern Pest - Military Hospital

    RECRUITING

    Budapest, 1068, Hungary

  • Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.

    RECRUITING

    Olsztyn, 10-424, Poland

  • Centrum Medyczne Dietla 19 Sp. z o.o.

    RECRUITING

    Krakow, 31-070, Poland

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinical Medical Research Sp. z o.o.

    RECRUITING

    Katowice, 40-156, Poland

  • Colorado Retina Associates

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Connecticut Eye Consultants, PC

    NOT_YET_RECRUITING

    Danbury, Connecticut, 06810, United States

  • Cumberland Valley Retina Consultants

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Doheny Eye Center UCLA Arcadia

    RECRUITING

    Pasadena, California, 91103, United States

  • East Florida Eye Institute

    NOT_YET_RECRUITING

    Stuart, Florida, 34994, United States

  • Eb Group Sp. z o.o.

    RECRUITING

    Warsaw, 00-189, Poland

  • Eye Research Foundation

    NOT_YET_RECRUITING

    Newport Beach, California, 92663, United States

  • F D Roosevelt University General Hospital Of Banska Bystrica

    RECRUITING

    Banská Bystrica, 974 01, Slovakia

  • Fakultna nemocnica Trencin

    RECRUITING

    Trenčín, 911 01, Slovakia

  • Fakultna nemocnica s poliklinikou Zilina

    RECRUITING

    Žilina, 101 01, Slovakia

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, 140 59, Czechia

    Contact Email: •••••@•••••

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, 100 00, Czechia

    Contact Email: •••••@•••••

  • Florida Retina Institute, Jacksonville Southside

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32216, United States

  • Frimley Park Hospital

    RECRUITING

    Camberley, GU16 7UJ, United Kingdom

  • Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, GL1 3NN, United Kingdom

  • Juntendo University Urayasu Hospital

    RECRUITING

    Urayasu-shi, 279-0021, Japan

  • Kagawa University Hospital

    RECRUITING

    Kita-gun, 761-0793, Japan

  • King's College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Kurume University Hospital

    RECRUITING

    Kurume-shi, 830-0011, Japan

  • Medical Center Ophthalmology Associates

    NOT_YET_RECRUITING

    San Antonio, Texas, 78240, United States

  • Moorfields Eye Hospital

    RECRUITING

    London, EC1V 2PD, United Kingdom

  • Musashi Dream Eye Clinic

    NOT_YET_RECRUITING

    Osaka, 543-0027, Japan

  • Nagoya City University Hospital

    RECRUITING

    Nagayoga, 467-8602, Japan

  • National Hospital Organization Tokyo Medical Center

    RECRUITING

    Meguro-ku, 152-8902, Japan

  • Nemocnica s poliklinikou Trebisov a.s.

    RECRUITING

    Trebišov, 075 01, Slovakia

  • North Carolina Retina Associates

    RECRUITING

    Wake Forest, North Carolina, 27587, United States

  • Northwick Park Hospital

    RECRUITING

    Harrow, HA1 3UJ, United Kingdom

  • Nozologen Kft.

    RECRUITING

    Pécs, 7621, Hungary

  • Oculomedica Sp. z o.o.

    RECRUITING

    Bydgoszcz, 85-157, Poland

  • Oftex s.r.o.

    RECRUITING

    Pardubice, 530 02, Czechia

    Contact Email: •••••@•••••

  • Piedmont Eye Center

    NOT_YET_RECRUITING

    Lynchburg, Virginia, 24502, United States

  • Poznanskie Centrum Wzroku sp z o o

    RECRUITING

    Poznan, 60-538, Poland

  • Retina Associates of Southern California

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Retina Center Of Texas

    RECRUITING

    Southlake, Texas, 76092, United States

  • Retina Consultants of Carolina, P.A.

    NOT_YET_RECRUITING

    Greenville, South Carolina, 29605, United States

  • Retina Consultants of San Diego

    RECRUITING

    Poway, California, 92064, United States

  • Retina Consultants of Texas

    RECRUITING

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Texas - Beaumont

    NOT_YET_RECRUITING

    Beaumont, Texas, 77707, United States

  • Retina Consultants, PLLC

    NOT_YET_RECRUITING

    Charleston, West Virginia, 25301, United States

  • Retina Group of Florida - Fort Lauderdale Retina Center

    NOT_YET_RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Retina Vitreous Associates of Florida

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Retinal Consultants Medical Group, Inc

    RECRUITING

    Modesto, California, 95356, United States

  • Retinal Consultants of San Antonio

    NOT_YET_RECRUITING

    San Antonio, Texas, 78240, United States

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, L7 8XP, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Shanghai General Hospital

    RECRUITING

    Shanghai, 200080, China

  • Shanxi Eye Hospital

    RECRUITING

    Taiyuan, 030072, China

  • Shijiazhuang People's Hospital

    RECRUITING

    Shijiazhuang, 050011, China

  • Shinshu University Hospital

    RECRUITING

    Matsumoto-shi, 390-8621, Japan

  • Sierra Eye Associates

    RECRUITING

    Reno, Nevada, 89502, United States

  • Southeast Retina Center, PC

    NOT_YET_RECRUITING

    Augusta, Georgia, 30909, United States

  • Southend University Hospital

    RECRUITING

    Westcliff-on-Sea, SS0 0RY, United Kingdom

  • Sunderland Eye Infirmary

    RECRUITING

    Sunderland, SR2 9HP, United Kingdom

  • Szpital Sw. Rozy Sp. z o.o.

    RECRUITING

    Krakow, 30-394, Poland

  • Szpital Swietego Lukasza S. A.

    RECRUITING

    Bielsko-Biala, 43-309, Poland

  • Tennessee Retina

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Fourth People's Hospital of Shenyang

    RECRUITING

    Shenyang, 110031, China

  • Tokiwadai Muranaka Eye Clinic

    NOT_YET_RECRUITING

    Itabashi-ku, 174-0071, Japan

  • Tokyo Medical University Hachioji Medical Center

    RECRUITING

    Hachioji-shi, 193-0998, Japan

  • Tokyo Women's Medical University Hospital

    RECRUITING

    Tokyo, 162-8666, Japan

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University Hospital Hradec Kralove (FNHK)

    RECRUITING

    Hradec Králové, 500 03, Czechia

    Contact Email: •••••@•••••

  • University Hospital Ostrava

    RECRUITING

    Ostrava-Poruba, 708 52, Czechia

    Contact Email: •••••@•••••

  • University of Debrecen

    RECRUITING

    Debrecen, 4032, Hungary

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Pecs

    RECRUITING

    Pécs, 7623, Hungary

  • University of Szeged

    RECRUITING

    Szeged, 6720, Hungary

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Mannheim GmbH

    RECRUITING

    Mannheim, 68167, Germany

  • Verum Research, LLC

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 128 00, Czechia

    Contact Email: •••••@•••••

  • Warszawski Szpital Okulistyczny Sp. z o.o.

    RECRUITING

    Warsaw, 01-258, Poland

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, 610041, China

  • West Coast Retina Medical Group, Inc.

    RECRUITING

    San Francisco, California, 94109, United States

  • Win Retina

    RECRUITING

    Arcadia, California, 91006, United States

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