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Study on the Effectiveness of Somatostatin Eye Drops for Patients with Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying Diabetic Retinopathy, a condition that affects the eyes of people with diabetes, leading to vision problems. The study is testing a new treatment called COLIRIOBCN070660, which is an eye drop containing the active substance somatostatin. Somatostatin is a type of protein that may help reduce or stop the damage to small blood vessels in the eye caused by diabetic retinopathy. The purpose of the study is to evaluate how effective these eye drops are in treating patients with moderately severe to severe non-proliferative diabetic retinopathy, a stage of the disease where new blood vessels have not yet started to grow.

Participants in the study will be randomly assigned to receive either the COLIRIOBCN070660 eye drops or a placebo, which looks like the real treatment but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The treatment will be administered twice daily for one year. Throughout the study, the number of small bulges in the blood vessels of the eye, known as microaneurysms, will be monitored to see if the treatment is effective in reducing or stopping their formation.

In addition to monitoring microaneurysms, the study will also look at other factors such as the number of small bleeds in the eye, changes in the thickness of the retina, and overall eye health using various imaging techniques. The study aims to provide valuable information on whether COLIRIOBCN070660 can help improve or maintain vision in people with diabetic retinopathy, potentially offering a new treatment option for this common complication of diabetes.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of diabetes, and severity of diabetic retinopathy.
Informed consent is required to participate in the trial.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the condition of the eyes using various tests such as Color Fundus Photography (CFP) and Optical Coherence Tomography (OCT).
The severity of diabetic retinopathy is determined, and baseline measurements are recorded.
Step 3
Medication administration
The medication, COLIRIOBCN070660, is administered as eye drops.
The dosage is twice daily for a duration of one year.
A placebo may be used for some participants as part of the study design.
Step 4
Regular follow-up visits
Regular follow-up visits are scheduled to monitor the condition of the eyes and the effectiveness of the treatment.
These visits include assessments using CFP, OCT, and other relevant tests to track changes in the eyes.
Step 5
Final assessment
At the end of the one-year period, a final assessment is conducted to evaluate the overall impact of the treatment.
The primary focus is on the reduction or arrest of microvascular impairment in the eyes.

Who can join the trial?

6 criteria

Men or women who are **18 years or older** at the time of signing the consent form.
Have a **diagnosis of diabetes mellitus**, which can be either type I or type II diabetes.
Have **moderately severe or severe NPDR** (a specific stage of diabetic eye disease) in the eye being studied, as determined by a specialized reading center.
Have a **BCVA ETDRS letter score** of 60 or more in the study eye, which is roughly equivalent to a vision of 20/63 or better on a standard eye chart.
Be willing and able to attend clinic visits and follow the procedures related to the study.
Provide a **signed informed consent**, which means agreeing to participate in the study after being informed about it.

Who cannot join the trial?

8 criteria

Patients who have any other eye disease that could affect the study results.
Patients who have had eye surgery in the last 6 months.
Patients who are currently using other treatments for diabetic retinopathy.
Patients who have a history of severe allergic reactions to eye drops.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients who have uncontrolled diabetes, meaning their blood sugar levels are not stable.
Patients who have a serious illness that could interfere with the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Costa del Sol
Marbella, Spain

Trial locations

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Investigated drugs

COLIRIOBCN070660 is a medication being tested in this clinical trial. It is applied directly to the eyes of patients who have a condition called non-proliferative diabetic retinopathy, which affects the blood vessels in the retina. The goal of using this medication is to see if it can help reduce or stop the formation of small bulges in the blood vessels, known as microaneurysms, which are common in this eye condition. The medication is used twice a day for a year to evaluate its effectiveness.

Somatostatin

What is already known about the treatment

COLIRIOBCN070660 – This medication is administered topically, typically in the form of eye drops, and is currently being evaluated in clinical trials for its effectiveness in treating diabetic retinopathy, specifically in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The main therapeutic indication is to reduce or halt the progression of microaneurysms in the retina, which are small bulges in blood vessels that can lead to vision problems. At the molecular level, the medication is believed to work by targeting specific pathways involved in blood vessel formation and stability, although the exact mechanism is still under investigation. It is classified pharmacologically as an ophthalmic agent, focusing on eye health and conditions.

Investigated diseases

Diabetic Retinopathy – Diabetic Retinopathy is a complication of diabetes that affects the eyes. It occurs when high blood sugar levels cause damage to the blood vessels in the retina, the light-sensitive tissue at the back of the eye. In its early stages, it may not cause any symptoms, but as it progresses, it can lead to vision problems. The disease is characterized by the presence of microaneurysms, hemorrhages, and other changes in the retinal blood vessels. Over time, these changes can lead to more severe forms of the disease, such as proliferative diabetic retinopathy, where new, abnormal blood vessels grow on the surface of the retina. If left unchecked, these changes can result in significant vision impairment.