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NCT06962839 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
A Phase 2 study of Macular Edema, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT06962839: Recruiting Phase 2 study of Macular Edema, sponsored by Boehringer Ingelheim.
NCT06962839 is a Phase 2 study of Macular Edema that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 300 participants, above the 158-participant average among 14 other Macular Edema trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06962839, a Phase 2 study of Macular Edema, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
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 |
What NCT06962839 shows while recruiting
NCT06962839 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 158-participant average among 14 other Macular Edema trials with a reported enrollment target (90% higher).
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.
NCT06962839 names 20 study sites across 12 states, led by California, Texas, Florida.
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.
What interventions are being tested in trial NCT06962839?
The interventions under investigation include: Placebo (DRUG), BI 1815368 (DRUG).
Who is sponsoring clinical trial NCT06962839?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06962839's enrollment target sits among peer trials
300 2nd of 14 the highest of 14 other Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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