Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxular Limited
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• Type 1 or Type 2 diabetes mellitus

• Diabetic Macular edema involving the center of the fovea in the study eye

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

Exclusion Criteria:

• Macular edema is considered due to a cause other than diabetes mellitus in the study eye

• Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema

• Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within 16 weeks prior to screening

• Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye

• Prior treatment with anti-VEGF in the study eye:

1. Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection.

2. Previously treated group (Part A and B), subjects in the previously treated group are excluded if they meet any of the below criteria for the study eye at screening:

1. Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).

2. Time interval between the first anti-VEGF injection and screening is more than 40 weeks.

3. Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.

4. Last injection with aflibercept within 8 weeks prior to screening.

5. Last injection with faricimab or brolucizumab within 12 weeks prior to screening.

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

• Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the study eye.

• Prior treatment with suprachoroidal steroids in the study eye is exclusionary.

• Active malignancy or history of malignancy within the past 5 years

• Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any other uncontrolled systemic disease at screening.