A Multi-Center, Randomized, Parallel-Group, Phase 2, Masked, Three-Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared with Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects with Diabetic Macular Edema (OXEYE).
This study is testing a new treatment called OXU-001 for an eye condition called diabetic macular edema (DME). DME happens when diabetes damages the tiny blood vessels in the eye, causing fluid to leak and swell the macula, which can blur your vision. The study wants to see how safe OXU-001 is and how well it works compared to an existing treatment, OZURDEX. Doctors will be checking to see if OXU-001 helps improve vision and reduces swelling in the eye, and how long these effects last. They will also be looking closely at any side effects from the new treatment or its delivery method. The goal is to find better ways to help people with DME keep their eyesight.
At a glance
What is this study about?
This study is a clinical trial exploring a new potential treatment for an eye condition called diabetic macular edema, often shortened to DME. DME can develop in people with diabetes and occurs when fluid builds up in a part of your eye called the macula, which is vital for sharp, central vision. This fluid build-up can make your vision blurry or distorted.
The study is comparing a new treatment, OXU-001, with a treatment that is already available, called OZURDEX. Both treatments involve giving medicine directly into the eye. OXU-001 uses a new way to deliver the medicine that aims to release it slowly over time, potentially meaning fewer treatments are needed. Researchers want to find out if OXU-001 is safe to use, how well it works to improve vision and reduce swelling in the eye, and how long its effects last compared to the existing treatment.
This trial is in what's known as 'Phase 2'. In this phase, researchers are primarily focused on safety and finding the right dose for the new treatment. They will be carefully monitoring participants for any side effects and seeing how well the medicine helps control DME. The results of this study will help determine if OXU-001 has the potential to become a new and effective treatment option for people living with diabetic macular edema.
Key takeaways
- This study explores a new treatment (OXU-001) for diabetic macular edema (DME).
- It compares OXU-001 with an existing treatment (OZURDEX).
- The main goals are to check the new treatment's safety and effectiveness.
- Participation involves eye treatments and regular clinic visits over about a year.
- You will be closely monitored for any side effects or changes in your vision.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women are welcome to take part. The main requirement is that you have diabetic macular edema (DME).
There might be other health conditions or medications that would prevent you from joining, but these will be checked carefully by the study doctors. It's important that you are able to attend all the scheduled appointments and follow the study instructions carefully.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have diabetic macular edema (DME)?
- Are you able to attend appointments regularly for about a year?
- Do you understand that you might receive the new treatment or an existing one?
What does participation involve?
If you decide to join this study, you'll be assigned to one of three groups by chance, like flipping a coin. Two groups will receive different doses of the new OXU-001 treatment, while the third group will receive the existing OZURDEX treatment. Both treatments are given into the eye.
You will have several visits to the clinic over a period of up to 52 weeks (about a year). During these visits, doctors will perform eye exams, measure your vision, and check the swelling in your eye. They will also ask you questions about your health and how you are feeling. Throughout the study, the medical team will be closely monitoring you for any side effects, both in your eye and generally, and providing any necessary follow-up care. The medical team will explain the full schedule and what each visit involves.
Potential risks and benefits
Locations (2)
- —UnverifiedHungary
- —UnverifiedSpain
Common questions
What is diabetic macular edema (DME)?
DME is an eye condition caused by diabetes, where fluid leaks into a part of your eye called the macula, causing blurry vision.
What is OXU-001?
OXU-001 is a new medicine being tested to treat DME that aims to release medicine slowly over time in the eye.
What is OZURDEX?
OZURDEX is an existing treatment for DME that is also given into the eye.
How long will the study last?
The study will last for up to 52 weeks, which is about one year, with regular visits to the clinic.
Will I know which treatment I'm getting?
No, this is a 'masked' study, meaning you won't know if you're getting OXU-001 or OZURDEX, nor will your study doctor, to keep the results unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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