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

NCT ID NCT06962839

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • 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

  • 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

  • Mid Atlantic Retina - Bethlehem

    NOT_YET_RECRUITING

    Bethlehem, Pennsylvania, 18017, United States

  • Moorfields Eye Hospital

    RECRUITING

    London, EC1V 2PD, United Kingdom

  • 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 San Diego

    RECRUITING

    Poway, California, 92064, United States

  • Retina Consultants of Texas

    RECRUITING

    The Woodlands, Texas, 77384, 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

  • 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

  • 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

  • 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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