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A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
NCT06962839 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG BI 1815368
Study Locations (20)
California
- Win Retina — Arcadia
- Retina Associates of Southern California — Huntington Beach
- Retinal Consultants Medical Group, Inc — Modesto
- Doheny Eye Center UCLA Arcadia — Pasadena
- Retina Consultants of San Diego — Poway
- West Coast Retina Medical Group, Inc. — San Francisco
Texas
- Austin Research Center for Retina, PLLC — Austin
- Austin Retina Associates — Austin
- Austin Clinical Research, LLC — Austin
Florida
- Advanced Research Institute — Pompano Beach
- Center for Retina and Macular Disease — Winter Haven
Colorado
- Colorado Retina Associates — Lakewood
Indiana
- Associated Vitreoretinal and Uveitis Consultants — Carmel
Kansas
- University of Kansas Medical Center — Kansas City
Maryland
- Cumberland Valley Retina Consultants — Hagerstown
Nevada
- Sierra Eye Associates — Reno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2027-09-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06962839
The ClinicalTrials.gov registry entry for NCT06962839 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Macular Edema appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06962839 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06962839 about?
NCT06962839 is a clinical study titled "A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema". 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...
What is the current status of trial NCT06962839?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2025-06-05. Estimated completion is 2027-09-29.
What conditions does trial NCT06962839 study?
This clinical trial studies the following conditions: Macular Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06962839?
The interventions under investigation include: Placebo (DRUG), BI 1815368 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06962839?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06962839 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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