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

(OXEYE Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for diabetic macular edema, a condition where fluid accumulates in the eye and impairs vision in people with diabetes. Researchers aim to determine which treatment is safer, more effective, and longer-lasting. Participants will receive either the new OXU-001 treatment (an experimental drug) using a special device or the standard Ozurdex® implant. Individuals with diabetes experiencing vision problems due to eye fluid may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, certain treatments for your eye condition, like recent anti-VEGF injections, may affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that OXU-001, a new treatment for diabetic macular edema, aims to reduce steroid-related side effects compared to current treatments. This could lead to fewer issues like changes in eye pressure. The treatment uses a tiny device to deliver medication directly into the eye.

Although detailed safety information about OXU-001 isn't widely available yet, it has passed some initial safety checks. Treatments at this stage have usually demonstrated some safety in earlier small studies, but new information can still emerge.

Ozurdex, the treatment compared in this study, has already received FDA approval for other eye conditions. This approval indicates its safety and general suitability for treating diabetic macular edema.

Prospective trial participants should know that these treatments aim to be safe, but risks may still exist. Discuss these risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about OXU-001 for diabetic macular edema because it offers a new way to deliver treatment directly to the eye. Unlike current treatments like Ozurdex® that are injected into the vitreous, OXU-001 is administered via suprachoroidal microcatheterization, potentially offering a more targeted approach with sustained release of the medication. This method uses dexamethasone acetate, which is designed to last longer and possibly reduce the frequency of treatments needed. This innovative delivery system could lead to better outcomes and fewer side effects for patients.

What evidence suggests that this trial's treatments could be effective for diabetic macular edema?

This trial will compare the effectiveness of OXU-001 and Ozurdex in treating diabetic macular edema. Research has shown that OXU-001, administered through a special eye procedure, is expected to reduce eye swelling for an extended period and may have fewer side effects than current steroid treatments. Early results suggest it could help decrease fluid buildup in the retina, which is crucial for treating diabetic macular edema. Meanwhile, Ozurdex, a tiny implant placed directly in the eye, has improved vision and reduced retinal swelling in people with diabetic macular edema. Studies have found that Ozurdex significantly enhances vision for many patients, with some experiencing major benefits in just a few months. This trial will study both treatments to determine which better manages eye swelling caused by diabetes. ^{1 2 3 4 5}

Who Is on the Research Team?

Friedrich Asmus, MD

Principal Investigator

Oxular Limited

Are You a Good Fit for This Trial?

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

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

I have diabetes (Type 1 or Type 2).

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ctv.veeva.com ctv.veeva.com/study/suprachoroidal-sustained-release-oxu-001-compared-to-intravitreal-ozurdex-r-in-the-treatment-of-diabe

Suprachoroidal Sustained-Release OXU-001 Compared to ... The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/09/NCT05697809/SAP_002.pdf

Parexel International OXU-001 is expected to have a sustained anti-edema effect and a reduced incidence of steroid-related ocular adverse events (AEs) compared to current standard ...

3. trial.medpath.com trial.medpath.com/clinical-trial/726d97c1ca826ce8/nct05697809-multi-center-randomized-trial-oxu-001-diabetic-macular-edema

Suprachoroidal Sustained-Release OXU-001 Compared to ... The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release ...

4. withpower.com withpower.com/trial/phase-2-macular-edema-2-2023-ef182

Suprachoroidal OXU-001 vs. Intravitreal Ozurdex for Diabetic ... The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release ...

5. clinicaltrials.eu clinicaltrials.eu/inn/dexamethasone-acetate-ph-eur/

DEXAMETHASONE ACETATE PH. EUR. (OXU-001) ... This article discusses clinical trials investigating the use of Dexamethasone Acetate Ph. Eur., specifically the drug OXU-001, for treating Diabetic Macular ...