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NCT06962839PHASE2Recruiting

A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

Boehringer Ingelheim

Start Date

6/5/2025

Completion Date

9/29/2027

Summary

This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months. Participants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BI 1815368

DRUG

Placebo

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Conditions

Macular Edema

Locations

Win Retina

Arcadia, California 91006

United States

Retina Associates of Southern California

Huntington Beach, California 92647

United States

Retinal Consultants Medical Group, Inc

Modesto, California 95356

United States

Doheny Eye Center UCLA Arcadia

Pasadena, California 91103

United States

Retina Consultants of San Diego

Poway, California 92064

United States

West Coast Retina Medical Group, Inc.

San Francisco, California 94109

United States

Colorado Retina Associates

Lakewood, Colorado 80228

United States

Advanced Research Institute

Pompano Beach, Florida 33064

United States

Center for Retina and Macular Disease

Winter Haven, Florida 33880

United States

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana 46032

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland 21740

United States

Sierra Eye Associates

Reno, Nevada 89502

United States

North Carolina Retina Associates

Wake Forest, North Carolina 27587

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Verum Research, LLC

Eugene, Oregon 97401

United States

Tennessee Retina

Nashville, Tennessee 37203

United States

Austin Research Center for Retina, PLLC

Austin, Texas 78705

United States

Austin Retina Associates

Austin, Texas 78705

United States

Austin Clinical Research, LLC

Austin, Texas 78750

United States

Texas Retina Associates

Dallas, Texas 75231

United States

Retina Center Of Texas

Southlake, Texas 76092

United States

Retina Consultants of Texas

The Woodlands, Texas 77384

United States

West China Hospital, Sichuan University

Chengdu, 610041

China

Shanghai General Hospital

Shanghai, 200080

China

The Fourth People's Hospital of Shenyang

Shenyang, 110031

China

Shijiazhuang People's Hospital

Shijiazhuang, 050011

China

Shanxi Eye Hospital

Taiyuan, 030072

China

University Hospital Hradec Kralove (FNHK)

Hradec Králové, 500 03

Czechia

University Hospital Ostrava

Ostrava-Poruba, 708 52

Czechia

Oftex s.r.o.

Pardubice, 530 02

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 00

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 00

Czechia

Fakultni Thomayerova nemocnice

Prague, 140 59

Czechia

Axon Clinical s.r.o.

Prague, 150 00

Czechia

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307

Germany

Universitätsklinikum Düsseldorf

Düsseldorf, 40225

Germany

Universitätsklinikum Leipzig

Leipzig, 04103

Germany

Universitätsklinikum Mannheim GmbH

Mannheim, 68167

Germany

Augenzentrum am St. Franziskus-Hospital Münster

Münster, 48145

Germany

Central Hospital of Northern Pest - Military Hospital

Budapest, 1068

Hungary

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, 1106

Hungary

Budapest Retina Associations Kft.

Budapest, 1133

Hungary

Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

Budapest, 1204

Hungary

University of Debrecen

Debrecen, 4032

Hungary

Nozologen Kft.

Pécs, 7621

Hungary

University of Pecs

Pécs, 7623

Hungary

University of Szeged

Szeged, 6720

Hungary

Asahikawa Medical University Hospital

Asahikawa-shi, 078-8510

Japan

Tokyo Medical University Hachioji Medical Center

Hachioji-shi, 193-0998

Japan

Kagawa University Hospital

Kita-gun, 761-0793

Japan

Kurume University Hospital

Kurume-shi, 830-0011

Japan

Shinshu University Hospital

Matsumoto-shi, 390-8621

Japan

National Hospital Organization Tokyo Medical Center

Meguro-ku, 152-8902

Japan

Nagoya City University Hospital

Nagayoga, 467-8602

Japan

Tokyo Women's Medical University Hospital

Tokyo, 162-8666

Japan

Juntendo University Urayasu Hospital

Urayasu-shi, 279-0021

Japan

Szpital Swietego Lukasza S. A.

Bielsko-Biala, 43-309

Poland

Oculomedica Sp. z o.o.

Bydgoszcz, 85-157

Poland

Clinical Medical Research Sp. z o.o.

Katowice, 40-156

Poland

Szpital Sw. Rozy Sp. z o.o.

Krakow, 30-394

Poland

Centrum Medyczne Dietla 19 Sp. z o.o.

Krakow, 31-070

Poland

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

Olsztyn, 10-424

Poland

Poznanskie Centrum Wzroku sp z o o

Poznan, 60-538

Poland

Caminomed Sp. z o.o.

Tarnowskie Góry, 42-600

Poland

Eb Group Sp. z o.o.

Warsaw, 00-189

Poland

Warszawski Szpital Okulistyczny Sp. z o.o.

Warsaw, 01-258

Poland

F D Roosevelt University General Hospital Of Banska Bystrica

Banská Bystrica, 974 01

Slovakia

Nemocnica s poliklinikou Trebisov a.s.

Trebišov, 075 01

Slovakia

Fakultna nemocnica Trencin

Trenčín, 911 01

Slovakia

Fakultna nemocnica s poliklinikou Zilina

Žilina, 101 01

Slovakia

Frimley Park Hospital

Camberley, GU16 7UJ

United Kingdom

Gloucestershire Royal Hospital

Gloucester, GL1 3NN

United Kingdom

Northwick Park Hospital

Harrow, HA1 3UJ

United Kingdom

Royal Liverpool University Hospital

Liverpool, L7 8XP

United Kingdom

Moorfields Eye Hospital

London, EC1V 2PD

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP

United Kingdom

Sunderland Eye Infirmary

Sunderland, SR2 9HP

United Kingdom

Southend University Hospital

Westcliff-on-Sea, SS0 0RY

United Kingdom