Suprachoroidal OXU-001 vs. Intravitreal Ozurdex for Diabetic Macular Edema
(OXEYE Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oxular Limited

No Placebo Group

Prior Safety Data

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.

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.

+8 more

Participant Groups

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.

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

Group III: A2: OXU-001 / High DoseExperimental Treatment2 Interventions

Group IV: A1: OXU-001 / Mid doseExperimental Treatment2 Interventions

Group V: B3: Ozurdex®Active Control1 Intervention

A single treatment with intravitreal Ozurdex®