Suprachoroidal OXU-001 vs. Intravitreal Ozurdex for Diabetic Macular Edema

(OXEYE Trial)

Recruiting at 17 trial locations

Overseen By Daniel Sea

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oxular Limited

Must not be taking: Anti-VEGF, Steroid injections

Disqualifiers: Active malignancy, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

3 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is 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.

Research Team

Friedrich Asmus, MD

Principal Investigator

Oxular Limited

Eligibility Criteria

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.

Inclusion Criteria

I have diabetes (Type 1 or Type 2).

I have swelling in the center of my retina due to diabetes.

Patients with Best corrected visual acuity in the study eye between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters

Exclusion Criteria

Prior treatment with SUSVIMO (Port Delivery System) implant is exclusionary

My macular edema is not caused by diabetes.

My eye condition is due to advanced diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Randomized, single-dose two treatment arm comparison of two dose levels of sustained-release suprachoroidal OXU-001

Single administration

1 visit (in-person)

Treatment Part B

Randomized, masked, active comparator, single-dose, three treatment arm comparison of two dose levels of suprachoroidal OXU-001 and IVT Ozurdex®

Single administration

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

• OXU-001
• Ozurdex® Ophthalmic Intravitreal Implant
• Semi-automated suprachoroidal illuminated microcatheter

Trial Overview 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.

Participant Groups

Group I: B2: OXU-001 / High Dose Experimental Treatment 2 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 Dose Experimental Treatment 2 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 Dose Experimental Treatment 2 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 dose Experimental Treatment 2 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 Control 1 Intervention

A single treatment with intravitreal Ozurdex®

Who Is Running the Clinical Trial?

Oxular Limited

Lead Sponsor

Trials

3

Recruited

30+