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Corticosteroid
Suprachoroidal OXU-001 vs. Intravitreal Ozurdex for Diabetic Macular Edema (OXEYE Trial)
Phase 2
Waitlist Available
Research Sponsored by Oxular Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 12 through week 52
Awards & highlights
No Placebo-Only Group
Summary
This trial compares safety, effectiveness, and lasting effects of two doses of a new treatment for diabetic macular edema vs. an existing treatment.
Who is the study for?
This trial is for people with Type 1 or Type 2 diabetes who have diabetic macular edema affecting the center of their retina. They should be able to see a certain amount but not too well (specific visual acuity range). Those who've had recent other eye treatments, cancer within 5 years, uncontrolled diabetes or diseases, and specific prior medications are excluded.
What is being tested?
The study compares two treatments for diabetic macular edema: OXU-001 delivered into the eye's choroid layer using a special device versus Ozurdex®, an existing treatment injected inside the eye. It looks at safety, how well they work, and how long they last.
What are the potential side effects?
Potential side effects may include discomfort in the eye where treated, increased risk of infection, possible changes in vision including blurriness or cataracts due to steroid use; individual reactions can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 12 through week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 12 through week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Other study objectives
Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest
Frequency and severity of treatment-emergent device adverse effects
Mean Change in Best-Corrected Visual Acuity (BCVA) compared to baseline, Visit 2, Day 0
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: B2: OXU-001 / High DoseExperimental Treatment2 Interventions
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied. This dose may be adpated based on the outcome of a Week 6 data review of Part A
Group II: B1: OXU-001 / Mid DoseExperimental Treatment2 Interventions
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
Group III: A2: OXU-001 / High DoseExperimental Treatment2 Interventions
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
Group IV: A1: OXU-001 / Mid doseExperimental Treatment2 Interventions
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
Group V: B3: Ozurdex®Active Control1 Intervention
A single treatment with intravitreal Ozurdex®
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Who is running the clinical trial?
Oxular LimitedLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
Friedrich Asmus, MDStudy DirectorOxular Limited
2 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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