A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device in Subjects With Diabetic Macular Edema

OXUCT-103 - CAPE

The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.

2022-08-31

2023-11-30

2023-11-30

Completed

Early phase I

20

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 of ≤73 (early treatment of diabetic retinopathy study) ETDRS letters (approximate Snellen equivalent of 20/40 or worse) * Short-lived, limited, or no response to prior ocular injection therapy 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 sixteen (16) weeks prior to screening. * Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye. * Active malignancy or history of malignancy within the past five years. * Prior intravitreal (IVT) treatment with anti-Vascular endothelial growth factor (VEGF) in the study eye: last injection within four weeks, before screening * Prior ocular treatment with steroids in the study eye: last injection (intra- or periocular) with triamcinolone acetonide within three (3) months, with dexamethasone implant (Ozurdex®) within six (6) months before screening. * Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary. * Prior treatment with suprachoroidal steroids is exclusionary. * Uncontrolled diabetes with a hemoglobin A1c (HbA1c) \> 12% or any other uncontrolled systemic disease at screening.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Two-Dose Group Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Subjects will be masked to the dose level of triamcinolone acetonide administered with the suprachoroidal Oxulumis® microcatheter', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2024-02-13