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

NCT ID: NCT06962839

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2027-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants in Cohort 1 will be randomised in a 1:1 ratio to placebo or BI 1815368 group.

Once Cohort 1 is fully recruited, Cohort 2 will be randomised in a 1:1:1:1 ratio to placebo or BI 1815368 low/medium/high dose groups.

There is no planned pause in recruitment between Cohort 1 and Cohort 2.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1: Treatment arm

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Cohort 1: Placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 1815368

Cohort 2: Placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 1815368

Cohort 2: Treatment arm, low dose

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Cohort 2: Treatment arm, medium dose

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Cohort 2: Treatment arm, high dose

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Interventions

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BI 1815368

BI 1815368

Intervention Type DRUG

Placebo

Placebo matching BI 1815368

Intervention Type DRUG

Eligibility Criteria

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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 for male and ≥305 µm for female participants in the study eye at screening

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 Vabysmo® or Eylea® HD), and within 6 months before Day 1 for Vabysmo® or Eylea® HD, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
* Any history of panretinal photocoagulation treatment, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of Iluvien® or Ozurdex® implants 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Win Retina

Arcadia, California, United States

Site Status NOT_YET_RECRUITING

Retina Associates of Southern California

Huntington Beach, California, United States

Site Status NOT_YET_RECRUITING

Retinal Consultants Medical Group, Inc

Modesto, California, United States

Site Status RECRUITING

Doheny Eye Center UCLA Arcadia

Pasadena, California, United States

Site Status NOT_YET_RECRUITING

Retina Consultants of San Diego

Poway, California, United States

Site Status NOT_YET_RECRUITING

West Coast Retina Medical Group, Inc.

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

Colorado Retina Associates

Lakewood, Colorado, United States

Site Status NOT_YET_RECRUITING

Advanced Research Institute

Pompano Beach, Florida, United States

Site Status RECRUITING

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Site Status NOT_YET_RECRUITING

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status NOT_YET_RECRUITING

Cumberland Valley Retina Consultants, PC.

Hagerstown, Maryland, United States

Site Status NOT_YET_RECRUITING

Sierra Eye Associates

Reno, Nevada, United States

Site Status NOT_YET_RECRUITING

North Carolina Retina Associates

Wake Forest, North Carolina, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

Verum Research, LLC

Eugene, Oregon, United States

Site Status NOT_YET_RECRUITING

Tennessee Retina

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Austin Research Center for Retina, PLLC

Austin, Texas, United States

Site Status RECRUITING

Austin Retina Associates

Austin, Texas, United States

Site Status RECRUITING

Austin Clinical Research, LLC

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

Texas Retina Associates

Dallas, Texas, United States

Site Status RECRUITING

Retina Center Of Texas

Southlake, Texas, United States

Site Status NOT_YET_RECRUITING

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, , China

Site Status NOT_YET_RECRUITING

Shanghai General Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

The Fourth People's Hospital of Shenyang

Shenyang, , China

Site Status NOT_YET_RECRUITING

Shijiazhuang People's Hospital

Shijiazhuang, , China

Site Status NOT_YET_RECRUITING

Shanxi Eye Hospital

Taiyuan, , China

Site Status NOT_YET_RECRUITING

University Hospital Hradec Kralove (FNHK)

Hradec Králové, , Czechia

Site Status NOT_YET_RECRUITING

University Hospital Ostrava

Ostrava-Poruba, , Czechia

Site Status NOT_YET_RECRUITING

Oftex s.r.o.

Pardubice, , Czechia

Site Status NOT_YET_RECRUITING

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Fakultni Thomayerova nemocnice

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Axon Clinical s.r.o.

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Mannheim GmbH

Mannheim, , Germany

Site Status NOT_YET_RECRUITING

Augenzentrum am St. Franziskus-Hospital Münster

Münster, , Germany

Site Status NOT_YET_RECRUITING

Central Hospital of Northern Pest - Military Hospital

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Budapest Retina Associations Kft.

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

University of Debrecen

Debrecen, , Hungary

Site Status NOT_YET_RECRUITING

Nozologen Kft.

Pécs, , Hungary

Site Status NOT_YET_RECRUITING

University of Pecs

Pécs, , Hungary

Site Status NOT_YET_RECRUITING

University of Szeged

Szeged, , Hungary

Site Status NOT_YET_RECRUITING

Asahikawa Medical University Hospital

Asahikawa-shi, , Japan

Site Status NOT_YET_RECRUITING

Tokyo Medical University Hachioji Medical Center

Hachioji-shi, , Japan

Site Status NOT_YET_RECRUITING

Kagawa University Hospital

Kita-gun, , Japan

Site Status NOT_YET_RECRUITING

Kurume University Hospital

Kurume-shi, , Japan

Site Status NOT_YET_RECRUITING

Shinshu University Hospital

Matsumoto-shi, , Japan

Site Status NOT_YET_RECRUITING

National Hospital Organization Tokyo Medical Center

Meguro-ku, , Japan

Site Status NOT_YET_RECRUITING

Nagoya City University Hospital

Nagoya, , Japan

Site Status NOT_YET_RECRUITING

Tokyo Women's Medical University Hospital

Shinjuku-ku, , Japan

Site Status NOT_YET_RECRUITING

Juntendo University Urayasu Hospital

Urayasu-shi, , Japan

Site Status NOT_YET_RECRUITING

Szpital Swietego Lukasza S. A.

Bielsko-Biala, , Poland

Site Status NOT_YET_RECRUITING

Oculomedica Sp. z o.o.

Bydgoszcz, , Poland

Site Status NOT_YET_RECRUITING

Clinical Medical Research Sp. z o.o.

Katowice, , Poland

Site Status NOT_YET_RECRUITING

Szpital Sw. Rozy Sp. z o.o.

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Centrum Medyczne Dietla 19 Sp. z o.o.

Krakow, , Poland

Site Status NOT_YET_RECRUITING

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

Olsztyn, , Poland

Site Status NOT_YET_RECRUITING

Poznanskie Centrum Wzroku sp z o o

Poznan, , Poland

Site Status NOT_YET_RECRUITING

Caminomed Sp. z o.o.

Tarnowskie Góry, , Poland

Site Status NOT_YET_RECRUITING

Eb Group Sp. z o.o.

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Warszawski Szpital Okulistyczny Sp. z o.o.

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

F D Roosevelt University General Hospital Of Banska Bystrica

Banská Bystrica, , Slovakia

Site Status NOT_YET_RECRUITING

Nemocnica s poliklinikou Trebisov a.s.

Trebišov, , Slovakia

Site Status NOT_YET_RECRUITING

Fakultna nemocnica s poliklinikou Zilina

Žilina, , Slovakia

Site Status NOT_YET_RECRUITING

Frimley Park Hospital NHS Foundation Trust

Frimley, , United Kingdom

Site Status NOT_YET_RECRUITING

Gloucestershire Royal Hospital

Gloucester, , United Kingdom

Site Status NOT_YET_RECRUITING

Northwick Park Hospital

Harrow, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status NOT_YET_RECRUITING

Moorfields Eye Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

King's College Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status NOT_YET_RECRUITING

Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status NOT_YET_RECRUITING

Southend University Hospital

Westcliff-on-Sea, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States China Czechia Germany Hungary Japan Poland Slovakia United Kingdom

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

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Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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U1111-1317-2206

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-520384-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

1485-0018

Identifier Type: -

Identifier Source: org_study_id