Ongoing Clinical Trials for Diabetic Retinopathy
There are currently 4 clinical trials underway studying new treatments for diabetic retinopathy, an eye condition that affects people with diabetes. These trials are testing different medications administered as eye drops, injections into the eye, or oral tablets. Trials are being conducted across multiple European countries including Spain, Germany, Hungary, Italy, Poland, Belgium, Greece, Latvia, Portugal, Slovakia, and Sweden.
Clinical trial locations
- Belgium
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Poland
- Portugal
- Slovakia
- Spain
- Study on BI 764524 for Patients with Moderate to Severe Diabetic Retinopathy
- Study on the Effectiveness and Safety of BAY 3283142 in Reducing Urine Albumin for Patients with Chronic Kidney Disease
- Study on the Effectiveness of Somatostatin Eye Drops for Patients with Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy
- Sweden
Study on BI 764524 for Patients with Moderate to Severe Diabetic Retinopathy
This trial is testing BI 764524, a medication given as an injection directly into the eye. The study aims to see if this treatment can help improve the eye condition in people with moderately-severe to severe non-proliferative diabetic retinopathy, a stage where the disease has caused significant damage to blood vessels but has not yet progressed to the most advanced form.
Inclusion criteria: Participants must be 18 years or older with a diagnosis of diabetes mellitus that is under regular treatment with blood sugar levels below 12%. They must have moderately severe to severe non-proliferative diabetic retinopathy confirmed by specialized imaging, with areas of the retina not getting enough blood supply. Vision must be at least 49 letters on a standard eye chart, and the eyes must be clear enough to allow quality imaging.
Exclusion criteria: People without diabetic retinopathy, those outside the specified age range, or those considered part of vulnerable populations requiring special protection cannot participate.
Study focus: The trial will last 72 weeks and compare BI 764524 to a sham injection procedure. The main goal is to observe if there is significant improvement in the eye condition after receiving the treatment. Regular check-ups will monitor eye health and any changes throughout the study period.
Investigational drug: BI 764524 is administered through intravitreal injection and works by targeting specific pathways at the molecular level to help reduce disease severity.
Study on the Effectiveness of Somatostatin Eye Drops for Patients with Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy
This trial is evaluating COLIRIOBCN070660, an eye drop containing somatostatin, a type of protein that may help reduce or stop damage to small blood vessels in the eye. The study will assess whether these eye drops are effective in treating patients with moderately severe to severe non-proliferative diabetic retinopathy.
Inclusion criteria: Participants must be 18 years or older with a diagnosis of either type I or type II diabetes. They must have moderately severe or severe non-proliferative diabetic retinopathy in the study eye and vision of 20/63 or better on a standard eye chart. Participants must be willing to attend clinic visits and follow study procedures.
Exclusion criteria: People with other eye diseases that could affect results, recent eye surgery within 6 months, current use of other treatments for the condition, history of severe allergic reactions to eye drops, pregnancy or breastfeeding, participation in another trial within 30 days, uncontrolled diabetes, or serious illness that could interfere with the study are excluded.
Study focus: This is a double-blind study where participants will be randomly assigned to receive either the active eye drops or a placebo twice daily for one year. The study will monitor the number of small bulges in blood vessels (microaneurysms), small bleeds in the eye, changes in retinal thickness, and overall eye health using various imaging techniques.
Investigational drug: COLIRIOBCN070660 is applied topically as eye drops and aims to reduce or halt the progression of microaneurysms in the retina by targeting specific pathways involved in blood vessel formation and stability.
Study on the Effectiveness and Safety of BAY 3283142 in Reducing Urine Albumin for Patients with Chronic Kidney Disease
While this trial focuses primarily on chronic kidney disease, it includes patients who may also have diabetic retinopathy as a complication of their diabetes. The study is evaluating BAY 3283142, an oral medication taken as a coated tablet, to see how well it reduces albumin in the urine, which is a sign that the kidneys are not working as well as they should.
Inclusion criteria: Participants must be at least 18 years old with kidney function measured by eGFR between 20 and 75 mL/min/1.73 m². Protein levels in urine should be between 200 mg/g and less than 3500 mg/g. Participants should be on the highest tolerated dose of blood vessel-relaxing medications (ACEI or ARB) that has been stable for at least 4 weeks. Any other kidney-related medications must also be stable for 4 weeks before screening.
Exclusion criteria: People with other serious health conditions that might interfere with the study, those who are pregnant or breastfeeding, recent heart attack or stroke, severe liver disease, current participation in another trial, history of drug or alcohol abuse, allergy to study medication, kidney transplant, uncontrolled high blood pressure, or inability to follow study procedures are excluded.
Study focus: The trial will last 16 weeks, during which participants will be randomly assigned to receive either BAY 3283142 or a placebo in addition to their standard care. Regular check-ups will monitor kidney function and urine albumin-creatinine ratio to determine the most effective dose for future studies.
Investigational drug: BAY 3283142 is taken orally and is believed to work by modulating pathways that affect kidney function. It is in Phase 2b clinical trials evaluating its potential to reduce albuminuria.
Study on the Safety and Use of AVT06 (Aflibercept) for Patients with Chorioretinal Vascular Diseases
This trial is studying AVT06, a pre-filled syringe version of aflibercept, for use in treating various chorioretinal vascular diseases including diabetic retinopathy, diabetic macular edema, and other blood vessel-related eye conditions. The study focuses on ensuring the pre-filled syringe is handled correctly and safely when injected into the eye.
Inclusion criteria: Participants must be at least 18 years old with a diagnosis of one or more specific eye conditions including diabetic retinopathy or diabetic macular edema. The study eye must be suitable for treatment with aflibercept. Participants must be able to read, understand, and sign an informed consent form and be willing to follow all study procedures. Specific contraception requirements apply for both males and females during treatment and for at least 3 months after the last injection.
Exclusion criteria: People with other eye diseases not part of the study, recent or planned eye surgery during the study, current eye infection or inflammation, allergies to study medications, participation in another trial simultaneously, serious illness affecting ability to participate, pregnancy or breastfeeding, history of drug or alcohol abuse, or inability to follow instructions or attend visits are excluded.
Study focus: The trial assesses how well the pre-filled syringe can be handled and administered safely. It monitors any potential side effects related to the eye following injection. There is an optional extension phase for continued observation.
Investigational drug: AVT06 is administered via intravitreal injection using a pre-filled syringe. It is an anti-angiogenic agent that works by targeting specific pathways involved in abnormal blood vessel growth and leakage in the retina, helping to reduce vision loss.
Summary
The four ongoing clinical trials for diabetic retinopathy reflect diverse approaches to treating this diabetes-related eye condition. Two trials focus specifically on different stages of the disease, testing medications administered directly into the eye through injections. One trial explores a more convenient eye drop formulation, while another examines an oral medication primarily for kidney disease in patients who may also have eye complications from diabetes.
Spain hosts the most trials with three studies, followed by Italy with two. Other countries including Germany, Hungary, Poland, Belgium, Greece, Latvia, Portugal, Slovakia, and Sweden are each hosting one or two trials. This geographic distribution demonstrates broad European interest in developing new treatment options.
The trials test different drug mechanisms including BI 764524 and AVT06 for intravitreal injection, COLIRIOBCN070660 as topical eye drops containing somatostatin, and BAY 3283142 as an oral tablet. Each study employs careful monitoring protocols with regular follow-up visits ranging from 16 weeks to 72 weeks to assess both safety and effectiveness of these investigational treatments.
