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Dexamethasone Acetate Ph. Eur.

This article discusses clinical trials investigating the use of Dexamethasone Acetate Ph. Eur., specifically the drug OXU-001, for treating Diabetic Macular Edema (DME). The trials aim to evaluate the safety, tolerability, efficacy, and durability of suprachoroidal OXU-001 compared to intravitreal dexamethasone implants in patients with DME. The study utilizes an innovative drug delivery method using the Oxulumis® Illuminated Microcatheterization Device for administering OXU-001 to the suprachoroidal space.

Table of Contents

What is Dexamethasone Acetate?

Dexamethasone Acetate PH. EUR., also known as OXU-001, is a corticosteroid medication being studied for the treatment of Diabetic Macular Edema (DME). Corticosteroids are powerful anti-inflammatory drugs that can help reduce swelling and inflammation in various parts of the body, including the eye.[1]

What is Diabetic Macular Edema?

Diabetic Macular Edema (DME) is a complication of diabetes that affects the eyes. It occurs when fluid builds up in the macula, the central part of the retina responsible for sharp, detailed vision. This fluid accumulation causes the macula to swell, leading to blurred or distorted central vision.[1]

How is OXU-001 Used?

OXU-001 is administered through a novel approach called suprachoroidal injection. This method uses a special device called the Oxulumis® Illuminated Microcatheterization Device. Here’s how it works:

  1. A tiny needle is inserted into the white part of the eye (sclera).
  2. A microcatheter is deployed into the suprachoroidal space, which is a layer between the white of the eye and the retina.
  3. The device has a light that confirms correct placement of the microcatheter.
  4. Once confirmed, OXU-001 is injected into this space.

This method allows for targeted delivery of the medication to the affected area of the eye.[1]

Potential Benefits

Researchers are studying OXU-001 to determine its potential benefits for patients with DME. Some of the hoped-for outcomes include:

  • Improved vision, measured by the ability to read more letters on an eye chart
  • Reduced swelling in the macula
  • Longer-lasting effects compared to current treatments
  • Improved quality of life related to vision[1]

Who Can Receive OXU-001?

The ongoing clinical trial has specific criteria for who can participate. Generally, candidates should:

  • Be at least 18 years old
  • Have been diagnosed with Type 1 or Type 2 diabetes
  • Have DME affecting the center of vision
  • Have certain levels of vision and retinal thickness as measured by special tests

There are also many factors that might exclude someone from receiving OXU-001, such as certain eye conditions, recent eye surgeries, or uncontrolled diabetes.[1]

Safety Considerations

As with any medical treatment, there are potential risks and side effects. The ongoing study is closely monitoring:

  • Any adverse events in the eye or elsewhere in the body
  • Changes in eye pressure
  • Any issues related to the injection procedure

It’s important to note that OXU-001 is still being studied, and not all potential side effects may be known at this time.[1]

Ongoing Research

OXU-001 is currently being studied in a Phase 2 clinical trial. This trial is comparing different doses of OXU-001 to an existing treatment called Ozurdex® (another form of dexamethasone). The study aims to evaluate:

  • The safety and tolerability of OXU-001
  • How long the effects of the treatment last
  • How well it improves vision and reduces macular swelling
  • How it impacts patients’ quality of life[1]

This research is crucial in determining whether OXU-001 could become a new treatment option for people with Diabetic Macular Edema in the future.

Aspect Details
Study Drug OXU-001 (Dexamethasone Acetate Ph. Eur.)
Condition Studied Diabetic Macular Edema (DME)
Study Design Multi-center, randomized, parallel-group, Phase 2 trial
Treatment Method Suprachoroidal injection using Oxulumis® Illuminated Microcatheterization Device
Comparison OXU-001 vs. Intravitreal Ozurdex® (dexamethasone implant)
Primary Endpoints Frequency and severity of ocular and systemic adverse events, device adverse effects
Secondary Endpoints Time to follow-on treatment, changes in visual acuity and central subfield thickness, quality of life measures
Study Duration Up to 58 weeks per participant

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, tolerability, and feasibility of suprachoroidal OXU-001 in subjects with Diabetic Macular Edema (DME). Additionally, the trials aim to assess the durability and efficacy of the treatment, including its impact on visual acuity, edema control, and vision-related quality of life.
  • How is OXU-001 administered in these trials? OXU-001 is administered using the Oxulumis® Illuminated Microcatheterization Device. This device deploys a therapeutic drug delivery-guiding illuminated ophthalmic microcatheter into the suprachoroidal space of the eye. The illumination confirms correct placement before the drug is administered.
  • What are the main inclusion criteria for participants? Key inclusion criteria include being at least 18 years old, diagnosed with Type 1 or Type 2 diabetes mellitus, having DME involving the center of the fovea with specific central subfield thickness, and having best-corrected visual acuity within a certain range. Participants must also agree to use appropriate contraception methods during the study period.
  • What are some of the main exclusion criteria? Main exclusion criteria include presence of significant ocular or non-ocular diseases that may interfere with the study, history of closed-angle glaucoma, prior treatment with certain ocular medications or procedures, uncontrolled diabetes or hypertension, and pregnancy or breastfeeding.
  • How long does the study last for each participant? The duration of the study for each participant will be a maximum of fifty-eight (58) weeks. This includes up to four weeks of screening, up to 14 days for baseline visit activities, and up to fifty-two weeks of post-treatment observation.

Ongoing Clinical Trials on Dexamethasone Acetate Ph. Eur.

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

    Not recruiting

    1 1 1
    Investigated drugs:
    Hungary Spain

Glossary

  • Diabetic Macular Edema (DME): A complication of diabetes that affects the eyes, where fluid accumulates in the macula (central part of the retina), causing swelling and potentially leading to vision loss.
  • Suprachoroidal: Referring to the space between the choroid (a layer of blood vessels) and the sclera (the white, outer layer of the eye). In this study, it's the target area for drug delivery.
  • Intravitreal: Referring to the space within the eye's vitreous cavity. In this study, it's mentioned in relation to traditional methods of drug delivery for eye treatments.
  • Best Corrected Visual Acuity (BCVA): The best vision a person can achieve with the help of corrective lenses, measured using standardized eye charts.
  • Central Subfield Thickness (CST): A measurement of the thickness of the central part of the retina, often used to assess the severity of macular edema.
  • Spectral Domain Optical Coherence Tomography (SD-OCT): An imaging technique that provides detailed cross-sectional images of the retina, used to measure retinal thickness and assess eye conditions.
  • Dexamethasone: A type of corticosteroid medication used to reduce inflammation in various parts of the body, including the eye.
  • Microcatheter: A very small, flexible tube used to deliver medications to specific areas within the body. In this study, it's used to deliver medication to the suprachoroidal space of the eye.

References

  1. http://clinicaltrials.eu/trial/study-comparing-oxu-001-and-intravitreal-dexamethasone-for-patients-with-diabetic-macular-edema/