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

NCT06962839 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Macular Edema

Interventions

DRUG

BI 1815368

BI 1815368

DRUG

Placebo

Placebo matching BI 1815368

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2027-09-01
Completion
2027-09-29
FDA Drug
Yes

Countries

  • United States
  • China
  • Czechia
  • Germany
  • Hungary
  • Japan
  • Poland
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962839 on ClinicalTrials.gov