In short
BI 764524 is an investigational drug currently being studied in clinical trials for the treatment of diabetic retinopathy, a serious eye condition affecting people with diabetes. These trials aim to evaluate the safety, tolerability, and effectiveness of BI 764524 in patients with various stages of diabetic retinopathy, including those who have undergone laser treatment and those with non-proliferative diabetic retinopathy.
At a glance
- Drug Name
- BI 764524
- Condition Studied
- Diabetic Retinopathy (various stages)
- Administration Method
- Intravitreal injection (into the eye)
- Trial Phases
- First-in-Human and Phase 2
- Primary Objectives
- Safety, tolerability, and efficacy assessment
- Key Outcome Measures
- Diabetic Retinopathy Severity Scale (DRSS) improvement, vision-threatening complications, visual acuity changes
- Trial Duration
- 5 months to 1.5 years
- Comparators
- Sham injections, Aflibercept (in US only)
What is BI 764524?
BI 764524 is a new investigational medicine being developed to treat eye conditions related to diabetes. It is currently being studied in clinical trials to determine its safety, effectiveness, and the best way to use it for patients with diabetic retinopathy.
What Conditions Does BI 764524 Treat?
BI 764524 is primarily being studied for the treatment of diabetic retinopathy. Diabetic retinopathy is an eye condition that affects people with diabetes. It occurs when high blood sugar levels damage the blood vessels in the retina, which is the light-sensitive tissue at the back of the eye. This can lead to vision problems and, if left untreated, can cause blindness.
Specifically, BI 764524 is being investigated for:
- Proliferative diabetic retinopathy (PDR) with diabetic macular ischemia (DMI): This is an advanced stage of diabetic retinopathy where new, abnormal blood vessels grow in the retina. DMI occurs when small blood vessels in the central part of the retina (macula) become blocked, reducing blood flow.
- Moderately severe to severe non-proliferative diabetic retinopathy: This is an earlier stage of diabetic retinopathy where damage to the retina is present, but new blood vessels haven't yet started to grow.
How is BI 764524 Administered?
BI 764524 is administered through intravitreal injections. This means the medicine is injected directly into the eye. The injection is typically given in a doctor's office or clinic. The frequency of injections may vary depending on the specific treatment plan and the results of ongoing clinical trials.
Clinical Trials and Research
BI 764524 is currently being studied in several clinical trials:
- The HORNBILL Study (NCT04424290): This is a first-in-human trial to study the safety and tolerability of BI 764524 in patients with proliferative diabetic retinopathy who have previously undergone laser treatment. The study has two parts:
- Single Rising Dose (SRD) part: Patients receive a single injection of BI 764524 at different dose levels.
- Multiple Dosing (MD) part: Patients receive multiple injections of BI 764524 or sham injections over time.
- The CRIMSON Study (NCT06321302): This is a larger study testing whether BI 764524 helps people with moderately severe to severe non-proliferative diabetic retinopathy. The study compares different dosing regimens of BI 764524 to sham injections and, in the USA, to aflibercept (a currently approved treatment for diabetic retinopathy).
Potential Benefits
While the full benefits of BI 764524 are still being studied, researchers are looking at several potential improvements for patients:
- Improvement in the severity of diabetic retinopathy, as measured by the Diabetic Retinopathy Severity Scale (DRSS)
- Prevention of vision-threatening complications
- Improvement in visual acuity (sharpness of vision)
- Reduction in central retinal thickness
- Prevention of worsening diabetic retinopathy
- Prevention of progression to proliferative diabetic retinopathy
- Prevention of diabetic macular edema (swelling in the central part of the retina)
Safety and Side Effects
As BI 764524 is still in clinical trials, its full safety profile is not yet known. The ongoing studies are carefully monitoring for any side effects or adverse events related to the treatment. Researchers are particularly interested in:
- Drug-related adverse events
- Ocular adverse events (side effects affecting the eye)
- Dose-limiting events (side effects that might limit the amount of medicine that can be given)
It's important to note that all medical treatments can have potential side effects, and the benefits and risks should be discussed with a healthcare provider. As research continues, more information about the safety and effectiveness of BI 764524 will become available.