BI 1815368 for Macular Edema

Recruiting at 88 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Proliferative retinopathy, Ocular inflammation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 48 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 1815368, to determine if it can improve vision in individuals with centre-involved diabetic macular edema (CI-DME), a condition related to diabetes. Participants will receive either the new medicine or a placebo (a pill with no active ingredients) to identify the optimal dose. The study seeks individuals with diabetes who have been diagnosed with CI-DME that impacts their daily life. Participants will take tablets twice a day for about 11 months, with regular check-ups to monitor vision and eye health. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, your diabetes medication should be stable for at least 30 days before starting the trial, and there should be no plans for major changes in your diabetes treatment.

Is there any evidence suggesting that BI 1815368 is likely to be safe for humans?

Research has shown that BI 1815368 is being tested as a pill for diabetic macular edema. This study is in the middle stage, providing some safety information, though more data is still being collected. The main goal is to determine if participants can take the treatment without problems and to identify any side effects.

Participants receive varying doses of the treatment, helping researchers find the safest and most effective amount. Detailed information on side effects is not yet available, but the study closely monitors for any health issues.

Overall, the safety of BI 1815368 remains under investigation. The trials are designed to quickly identify and address any side effects. Participants undergo regular checks to ensure the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for macular edema?

Researchers are excited about BI 1815368 for macular edema because it offers a new approach compared to standard treatments like anti-VEGF injections. Unlike these existing therapies that primarily target vascular endothelial growth factor to reduce fluid in the retina, BI 1815368 might work through a different mechanism, potentially offering benefits for patients who do not respond well to current options. Additionally, the trial explores varying doses, which could help fine-tune the most effective and safe amount for treatment, offering hope for more personalized therapy.

What evidence suggests that BI 1815368 might be an effective treatment for macular edema?

Research shows that BI 1815368 might help people with diabetic macular edema by reducing fluid leakage in the eye. It achieves this by making new blood vessels less leaky. Early results suggest this could improve vision for those with the condition. Although clinical data collection is ongoing, this approach appears promising for treating this type of vision problem. Participants in this trial will receive different doses of BI 1815368 or a placebo to evaluate its effectiveness and safety. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults over 18 with diabetic macular edema, specifically centre-involved diabetic macular edema (CI-DME), can join this study. They must have a certain thickness in their retina and controlled diabetes with no major medication changes planned. Good enough vision is required but not perfect.

Inclusion Criteria

I have diabetes with HbA1c below 12% and stable medication for 30 days.

My eye condition involves swelling in the center of the retina, confirmed by a special eye scan.

My vision in the study eye ranges from 20/320 to 20/32.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take BI 1815368 or placebo tablets twice a day for about 11 months

48 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1815368

Trial Overview The trial tests if BI 1815368 improves sight for CI-DME patients. It has two parts: one compares the drug to a placebo, and the other tests different doses of BI 1815368 against a placebo. Participants take tablets twice daily for about 11 months and are monitored for a year.

How Is the Trial Designed?

Group I: Cohort 2: Treatment arm, medium dose Experimental Treatment 1 Intervention

Group II: Cohort 2: Treatment arm, low dose Experimental Treatment 1 Intervention

Group III: Cohort 2: Treatment arm, high dose Experimental Treatment 1 Intervention

Group IV: Cohort 1: Treatment arm Experimental Treatment 1 Intervention

Group V: Cohort 1: Placebo arm Placebo Group 1 Intervention

Group VI: Cohort 2: Placebo arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06962839

NCT06962839 | A Study to Test Whether BI 1815368 Helps ... 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 ...

2. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-diabetic-macular-edema

Phase II start of oral treatment for diabetic macular edema BI 1815368 has the potential to treat and prevent fluid leakage by reducing the permeability of newly formed blood vessels. Unlike other ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/boehringer-bi-1815368/

Boehringer begins trial of BI 1815368 for diabetic macular ... Boehringer Ingelheim has initiated the THULITE Phase II trial to evaluate the safety, tolerability and efficacy of BI 1815368.

4. modernretina.com modernretina.com/view/thulite-phase-ii-study-evaluates-bi-1815368

THULITE phase II study evaluates BI 1815368 THULITE will evaluate the efficacy, safety, and tolerability of BI 1815368, an oral medication for the treatment of diabetic macular edema (DME).

5. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/macular-edema

UCLA Macular Edema Clinical Trials for 2025 — Los Angeles 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 ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-test-whether-bi-1815368-helps-people-with-an-eye-condition-called-diabetic-macular-edema

A Study to Test Whether BI 1815368 Helps People With an ... 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.