A study to test whether BI 1815368 helps people with an eye condition called diabetic macular edema

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

20 Nov 2025 → ongoing

Decision date (initial)

2025-10-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Boehringer Ingelheim International GmbH

External identifiers

EU CT number

2024-520384-14-00

WHO UTN

U1111-1317-2206

ClinicalTrials.gov

NCT06962839

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Pharmacodynamic, Others, Pharmacokinetic, Pharmacogenetic, Safety

Evaluate the dose-response relationship for BI 1815368 in participants with varying levels of vision impairment due to CI-DME

Secondary objectives 2

1. Evaluate the difference in proportions of participants with ≥15-letter gain in ETDRS compared with baseline across different dose regimens and placebo in the study eye at Week 48
2. Investigating the safety profile of BI 1815368 (defined as the occurrence of drug-related adverse events [AEs] between baseline and end of study [EoS]) and evaluating the change in central subfield foveal thickness (CST) (using spectral domain optical coherence tomography [SD-OCT]) following administration of BI 1815368 at Week 48 compared with baseline across different dose regimens and placebo

Conditions and MedDRA coding

Centre-involved diabetic macular edema

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. ≥18 years of age
2. Diagnosis of diabetes mellitus (DM) (type 1 or type 2), 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
3. CI-DME confirmed on SD-OCT with CST ≥320 µm in the study eye at screening
4. BCVA visual acuity ETDRS letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening
5. Further inclusion criteria apply

Exclusion criteria 7

1. Macular edema considered to be due to other causes than CI-DME in the study eye
2. Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
3. Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8 mg), 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
4. Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
5. Active ocular inflammation of any history of intraocular inflammation within 1 year
6. Aphakia or total absence of the posterior capsule; YAG laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1
7. Further exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48

Secondary endpoints 3

1. Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48
2. Occurrence (yes/no) of drug-related AEs over the treatment period through EoS
3. Absolute change from baseline of CST as measured by SD-OCT in the study eye at Week 48

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 9

Locations

5 EU/EEA countries · 35 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 132 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications