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Study of oral BI 1815368 compared to placebo in patients with diabetic macular edema over 48 weeks of treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on diabetic macular edema, a condition affecting the eyes of people with diabetes that causes swelling in the central part of the retina. The research evaluates a new medication called BI 1815368 taken as oral tablets, which is being tested to determine if it can help improve vision in people with this eye condition.

The purpose of this research is to understand how different doses of BI 1815368 affect vision improvement in people who have varying levels of vision problems due to diabetic macular edema. The study will compare the new medication to placebo over a treatment period of 48 weeks.

During the study, participants will take tablets by mouth and have their vision regularly checked. The research team will monitor how well participants can see using standard eye tests and measure the thickness of the retina using special imaging equipment. They will also keep track of any effects that might be related to the treatment to ensure participant safety throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo an eye examination to confirm the presence of diabetic macular edema, a condition where fluid builds up in the central part of the retina.

    Your vision will be tested using special ETDRS charts (standard eye test charts) to measure your current vision level.

    A scan called SD-OCT will be performed to measure the thickness of your retina.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either BI 1815368 tablets or placebo tablets (tablets with no active medication).

    Neither you nor your doctor will know which treatment you are receiving during the study.

  3. Step 3

    Treatment period

    The treatment period will last for 48 weeks (approximately 11 months).

    You will take the assigned tablets by mouth according to the prescribed schedule.

    Your diabetes medication must remain stable throughout the study period.

  4. Step 4

    Regular monitoring

    Regular eye examinations will be conducted to measure your vision using the ETDRS charts.

    Retinal thickness measurements will be taken using SD-OCT scans.

    Your overall health and any side effects will be monitored throughout the study.

  5. Step 5

    Final assessment

    At week 48, final measurements of your vision will be taken to determine if there has been an improvement of 10 or more letters on the eye chart.

    A final retinal thickness measurement will be performed.

    Any side effects that occurred during the study will be reviewed.

Who can join the trial?

9 criteria

  • Must be at least 18 years old
  • Must have been diagnosed with diabetes (either type 1 or type 2) with:
    • Blood sugar control test (HbA1c) less than 12%
    • Stable diabetes medication for at least 30 days before starting the study
    • No planned major changes to diabetes medication
    • Must have diabetic macular edema (swelling in the central part of the retina) that meets specific thickness measurements:
      • For men: at least 320 micrometers
      • For women: at least 305 micrometers
      • Must have specific levels of vision in the study eye, measured using a standard eye chart (ETDRS):
        • Vision must be between 24 and 78 letters on the eye chart
        • This is approximately equal to vision between 20/320 and 20/32 on a standard vision test
        • Additional eligibility requirements may apply

Who cannot join the trial?

15 criteria

  • Age under 18 years or over 75 years
  • Pregnancy or breastfeeding
  • History of macular degeneration (damage to the central part of the retina) other than diabetic macular edema
  • Active eye infection or inflammation
  • Previous eye surgery within the last 3 months
  • Uncontrolled diabetes (blood sugar levels that remain high despite treatment)
  • Presence of other serious eye conditions such as glaucoma (increased pressure in the eye)
  • History of blood clotting disorders
  • Current participation in other clinical trials
  • Known allergies to similar medications
  • Severe heart, kidney, or liver disease
  • History of stroke or heart attack in the past 6 months
  • Use of blood thinning medications
  • Mental conditions that could affect ability to provide informed consent
  • Any condition that, in the opinion of the investigator, would make participation unsafe
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Investigated drugs

Based on the provided trial data, only one medication is mentioned: BI 1815368 is an oral medication being tested for treating diabetic macular edema (DME), a condition where fluid builds up in the center of the retina causing vision problems in people with diabetes. This is a new investigational drug that is taken by mouth, which is notable because most current treatments for DME are given as eye injections.

What is already known about the treatment

BI 1815368 - An oral medication currently being investigated in clinical trials for the treatment of center-involved diabetic macular edema (CI-DME), a serious eye condition that affects diabetic patients. The drug is administered in tablet form taken by mouth, representing a potential alternative to current injectable treatments for macular edema. While its exact molecular mechanism of action is still under investigation in clinical trials, this experimental compound is being studied for its ability to potentially reduce retinal swelling and improve vision in patients with diabetic eye complications. The medication is currently undergoing Phase 2 clinical trials to evaluate its safety, efficacy, and optimal dosing in patients with varying levels of vision impairment due to diabetic macular edema.

Investigated diseases

Centre-involved diabetic macular edema – A condition that occurs when blood vessels in the central part of the retina (macula) become damaged due to diabetes, causing them to leak fluid. This fluid accumulation leads to swelling in the central portion of the retina, affecting the area responsible for detailed vision. The condition typically develops gradually in people who have diabetic retinopathy. As the fluid builds up in the macula, it causes distortion of central vision and can make everyday tasks like reading or recognizing faces more difficult. The condition can affect one or both eyes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520384-14-00Protocol code1485-0018Estimated enrolment300 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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