Not recruiting

Study Comparing OXU-001 and Intravitreal Dexamethasone for Patients with Diabetic Macular Edema

Verified siteRegistered drugNo 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 a condition called Diabetic Macular Edema (DME), which affects the eyes of people with diabetes. The study is comparing two treatments to see which is safer and more effective. One treatment involves a new medication called OXU-001, which is a form of the drug dexamethasone delivered using a special device called the Oxulumis® Illuminated Microcatheterization Device. This device helps deliver the medication directly to the back of the eye in a minimally invasive way. The other treatment being studied is an existing medication called OZURDEX, which is also a form of dexamethasone but is delivered as an implant directly into the eye.

The purpose of the study is to compare the safety, tolerability, and effectiveness of these two treatments in people with DME. Participants in the study will be randomly assigned to receive either the OXU-001 treatment or the OZURDEX treatment. The study will be conducted over a period of time, and participants will have regular check-ups to monitor their eye health and any side effects they may experience. The study aims to determine which treatment provides better results in terms of reducing the swelling in the eye caused by DME and improving vision.

Throughout the study, participants will be closely monitored for any adverse effects related to the treatments or the devices used. The study will also assess how long the effects of the treatments last and how often additional treatments are needed. By the end of the study, researchers hope to gather valuable information that could lead to improved treatment options for people with Diabetic Macular Edema.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed. This includes checking your medical history and conducting a physical examination.
You will be asked to sign an informed consent form, which confirms that you understand the trial and agree to participate.
Step 2
Baseline assessment
A baseline assessment will be conducted to gather initial data. This includes measuring your Best Corrected Visual Acuity (BCVA) and the thickness of the central part of your retina using a special imaging technique.
These measurements will help in comparing changes over the course of the trial.
Step 3
Treatment administration
You will be randomly assigned to one of three groups. Two groups will receive the OXU-001 treatment, and one group will receive the OZURDEX implant.
The OXU-001 treatment involves an injection into the eye using a special device. The OZURDEX implant is placed inside the eye using an applicator.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor your progress. These visits will include eye examinations and assessments of your vision.
The frequency and duration of these visits will be explained to you by the study team.
Step 5
Final assessment
At the end of the trial, a final assessment will be conducted. This will include a comprehensive eye examination and a review of any changes in your vision.
The results will be compared to the baseline assessment to evaluate the effectiveness and safety of the treatment.

Who can join the trial?

8 criteria

Able to understand and sign an informed consent form.
At least 18 years old at the time of screening.
Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
Have Diabetic Macular Edema (DME) affecting the center of the fovea, with a specific thickness in the study eye, confirmed by a test called SD OCT (a type of eye scan).
Have a certain level of vision in the study eye, measured by a test called ETDRS, which is similar to the Snellen eye chart test (20/200-20/32 vision).
For women who are not postmenopausal (not having periods for at least 12 months without medical reasons or surgery), agree to remain abstinent or use effective birth control methods with a failure rate of less than 1% per year during the study and for at least 52 weeks after treatment.
Males must agree to use a barrier method of contraception (like a condom) during the study and for at least 52 weeks after treatment.
Must agree not to participate in any other clinical trial involving new medicines or devices until the end of this study.

Who cannot join the trial?

9 criteria

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery in the last three months.
Patients who are currently using or have used certain medications that could interfere with the study.
Patients with a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with uncontrolled diabetes, meaning their blood sugar levels are not stable.
Patients with any serious health conditions that could make participation unsafe.
Patients who are unable to follow the study procedures or attend all required visits.

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Verified sites

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

Clinica De Oftalmologia De Cordoba S.L.
Verified
Cordoba, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitari General De Catalunya
Verified
Sant Cugat Del Valles, Spain

Trial locations

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Investigated drugs

OXU-001
is a new form of medication designed to help people with Diabetic Macular Edema, a condition that affects the eyes. It uses tiny particles called microspheres to slowly release a medicine called dexamethasone directly into the eye. This method aims to reduce swelling and improve vision over time. The medication is delivered using a special device that helps place it in the right part of the eye.
OZURDEX
is a type of implant that is placed inside the eye to treat Diabetic Macular Edema. It contains dexamethasone, a medicine that helps reduce inflammation and swelling in the eye. The implant slowly releases the medication over time, which can help improve vision and reduce symptoms associated with the condition. This treatment is already used in medical practice and is being compared to the new OXU-001 treatment in the trial.

What is already known about the treatment

DEXAspheres® (Dexamethasone Microspheres) – This medication is administered using a special device called the Oxulumis® Illuminated Microcatheterization Device, which delivers the drug directly to the back of the eye in a procedure known as suprachoroidal injection. Currently, DEXAspheres® is being studied in clinical trials for its safety and effectiveness in treating Diabetic Macular Edema (DME), a condition that affects vision. The drug works by releasing dexamethasone, a type of steroid, slowly over time to reduce inflammation and swelling in the eye. It is classified as a corticosteroid, which is a group of medications used to decrease inflammation in various conditions.

Investigated diseases

Diabetic Macular Edema – Diabetic Macular Edema (DME) is a condition that affects the eyes, specifically the macula, which is the part of the retina responsible for sharp, central vision. It occurs when blood vessels in the retina become damaged due to high blood sugar levels, leading to fluid leakage and swelling in the macula. This swelling can cause vision to become blurry or wavy, and colors may appear washed out. Over time, if the swelling persists, it can lead to more significant vision impairment. The progression of DME is often gradual, and it is commonly associated with diabetic retinopathy, a complication of diabetes that affects the eyes. Regular monitoring and management of blood sugar levels are crucial in managing the progression of this condition.