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

Completed · Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT05697809

Run by

Oxular Limited

People needed

3

Starts

2023-08-07

Expected to finish

2024-12-05

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection.
• 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:
• Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).
• Time interval between the first anti-VEGF injection and screening is more than 40 weeks.
• Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.
• Last injection with aflibercept within 8 weeks prior to screening.
• Last injection with faricimab or brolucizumab within 12 weeks prior to screening.
• 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.

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Blue Ocean Clinical Research West — Clearwater, Florida, United States
• University Retina and Macula Associates — Oak Forest, Illinois, United States
• Retina Consultants of Minnesota — Minneapolis, Minnesota, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Retina Consultants of Texas — Houston, Texas, United States
• Valley Retina Institute, PA — McAllen, Texas, United States
• Retinal Consultants of Texas - San Antonio — San Antonio, Texas, United States
• Emmanuelli Research and Development Center, LLC — Arecibo, Puerto Rico

Full record on ClinicalTrials.gov

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