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Suprachoroidal OXU-001 vs. Intravitreal Ozurdex for Diabetic Macular Edema (OXEYE Trial)
OXEYE Trial Summary
This trial compares safety, effectiveness, and lasting effects of two doses of a new treatment for diabetic macular edema vs. an existing treatment.
OXEYE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OXEYE Trial Design
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Who is running the clinical trial?
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- My macular edema is not caused by diabetes.My eye condition is due to advanced diabetes.My vision isn't expected to get better even if the swelling in my eye improves.I have not been excluded based on specific criteria for my study eye.I had laser treatment on my eye within the last 16 weeks.I have had eye treatments with steroid injections or implants in my study eye.I have not received any IVT anti-VEGF treatments in my study eye.My diabetes or another systemic disease is not under control.I have diabetes (Type 1 or Type 2).I have swelling in the center of my retina due to diabetes.I have not had steroid treatments in my eye.I have had cancer or still have it within the last 5 years.
- Group 1: B1: OXU-001 / Mid Dose
- Group 2: A2: OXU-001 / High Dose
- Group 3: B2: OXU-001 / High Dose
- Group 4: B3: Ozurdex®
- Group 5: A1: OXU-001 / Mid dose
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the potential risks involved with ingesting A1: OXU-001 / Mid dose?
"Our team at Power has deemed A1: OXU-001 / Mid dose with a score of 2 on the safety scale, as this is a Phase 2 trial which indicates that there are limited data suggesting its efficacy but some information highlighting its security."
Are there currently any prospective participants for this research project?
"Affirmative. According to the particulars found on clinicaltrials.gov, this medical trial is currently recruiting participants and was originally published in late July of 2023 with an update following a few weeks later. 128 people are necessary for enrolment at 9 sites across the country."
How many participants are currently enrolled in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the trial is recruiting patients - it was established on July 31st 2023 and recently edited on July 14th of that same year. 128 study participants are sought after from 9 distinct medical centres."
Are there multiple US-based medical facilities actively participating in this research?
"At the present moment, 9 healthcare centres are recruiting for this trial. These sites can be found in Clearwater, Oak Forest and Minneapolis as well as 6 other cities; so it is advisable to pick an institution that's close by if you join the study."
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