Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Study Overview
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Brief Summary
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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.

Detailed Description
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Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema. After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be randomized using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Device: Semi-automated Suprachoroidal Microcatheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Two-Dose Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprachoroidal Triamcinolone acetonide 2.4mg<br>The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied. | Drug: Triamcinolone Acetonide<br>* Single suprachoroidal Administration of Triamcinolone acetonide<br>* Other names: Triesence®;Device: Semi-automated Suprachoroidal Microcatheter<br>* Ophthalmic Adminstration Device<br>* Other names: Oxulumis®;|
| Experimental: Suprachoroidal Triamcinolone acetonide 4.0mg<br>The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied. | Drug: Triamcinolone Acetonide<br>* Single suprachoroidal Administration of Triamcinolone acetonide<br>* Other names: Triesence®;Device: Semi-automated Suprachoroidal Microcatheter<br>* Ophthalmic Adminstration Device<br>* Other names: Oxulumis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events | Treatment-emergent adverse events are defined as an event that emerges following administration of Triesence® with the Oxulumis® microcatheter administered at Visit 2 (Baseline, Day 0) | 24 Weeks | 
| Frequency of adverse device effects and frequency of serious adverse device effects | Adverse device effects and serious adverse device effects are defined as effects that emerge following the administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0) | 24 Weeks |