Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema (OXEYE)
Diabetic Macular Edema
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Macular Edema, Edema, Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Immunosuppressive Agents, Immunologic Factors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Dexamethasone, Suprachoroidal Microcatheterization, Illuminated Microcatheterization, Sustained-Release
Eligibility 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: 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.
Sites / Locations
- Retinal Research Institute, LLCRecruiting
- Blue Ocean Clinical Research WestRecruiting
- University Retina and Macula AssociatesRecruiting
- Retina Consultants of MinnesotaRecruiting
- Sierra Eye AssociatesRecruiting
- Retina Consultants of TexasRecruiting
- Valley Retina Institute, PARecruiting
- Retinal Consultants of Texas - San AntonioRecruiting
- Emmanuelli Research and Development Center, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
A1: OXU-001 / Mid dose
A2: OXU-001 / High Dose
B1: OXU-001 / Mid Dose
B2: OXU-001 / High Dose
B3: Ozurdex®
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.
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.
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.
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
A single treatment with intravitreal Ozurdex®