A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Public ClinicalTrials.gov record NCT06962839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06962839
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 4, 2025
- Primary completion
- Aug 31, 2027
- Completion
- Sep 28, 2027
- Last update posted
- Sep 2, 2026
2025 – 2027
United States locations
- U.S. sites
- 37
- U.S. states
- 18
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Retina & Vitreous Research, Central Phoenix | Phoenix | Arizona | 85016 | Not yet recruiting |
| Win Retina | Arcadia | California | 91006 | Recruiting |
| Retina Associates of Southern California | Huntington Beach | California | 92647 | Recruiting |
| Retinal Consultants Medical Group, Inc | Modesto | California | 95356 | Recruiting |
| Eye Research Foundation | Newport Beach | California | 92663 | Not yet recruiting |
| Doheny Eye Center UCLA Arcadia | Pasadena | California | 91103 | Recruiting |
| Retina Consultants of San Diego | Poway | California | 92064 | Recruiting |
| West Coast Retina Medical Group, Inc. | San Francisco | California | 94109 | Recruiting |
| Colorado Retina Associates | Lakewood | Colorado | 80228 | Recruiting |
| Connecticut Eye Consultants, PC | Danbury | Connecticut | 06810 | Not yet recruiting |
| Retina Group of Florida - Fort Lauderdale Retina Center | Fort Lauderdale | Florida | 33308 | Not yet recruiting |
| Florida Retina Institute, Jacksonville Southside | Jacksonville | Florida | 32216 | Not yet recruiting |
| Advanced Research Institute | Pompano Beach | Florida | 33064 | Recruiting |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | Not yet recruiting |
| East Florida Eye Institute | Stuart | Florida | 34994 | Not yet recruiting |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | Recruiting |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | Not yet recruiting |
| Associated Vitreoretinal and Uveitis Consultants | Carmel | Indiana | 46032 | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Recruiting |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | Recruiting |
| Sierra Eye Associates | Reno | Nevada | 89502 | Recruiting |
| North Carolina Retina Associates | Wake Forest | North Carolina | 27587 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Not yet recruiting |
| Verum Research, LLC | Eugene | Oregon | 97401 | Recruiting |
| Retina Consultants of Carolina, P.A. | Greenville | South Carolina | 29605 | Not yet recruiting |
| Tennessee Retina | Nashville | Tennessee | 37203 | Recruiting |
| Austin Research Center for Retina, PLLC | Austin | Texas | 78705 | Recruiting |
| Austin Retina Associates | Austin | Texas | 78705 | Not yet recruiting |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | Recruiting |
| Retina Consultants of Texas - Beaumont | Beaumont | Texas | 77707 | Not yet recruiting |
| Texas Retina Associates | Dallas | Texas | 75231 | Recruiting |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | Not yet recruiting |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | Not yet recruiting |
| Retina Center Of Texas | Southlake | Texas | 76092 | Recruiting |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | Recruiting |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | Not yet recruiting |
| Retina Consultants, PLLC | Charleston | West Virginia | 25301 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06962839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06962839 live on ClinicalTrials.gov.