Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Phase 2

Completed

Interventions: Drug: Triamcinolone Acetonide
Device: Semi-automated Suprachoroidal Microcatheter

Brief Summary: 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: 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 treated 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). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Suprachoroidal Triamcinolone acetonide 2.4mg	Triamcinolone Acetonide	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.
Suprachoroidal Triamcinolone acetonide 2.4mg	Semi-automated Suprachoroidal Microcatheter	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.
Suprachoroidal Triamcinolone acetonide 4.0mg	Triamcinolone Acetonide	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.
Suprachoroidal Triamcinolone acetonide 4.0mg	Semi-automated Suprachoroidal Microcatheter	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events	Day 0 up to Week 24 (per protocol individual trial duration per participant)	Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects	Day 0 up to Week 24 (per protocol individual trial duration per participant)	Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)

Secondary Outcome Measures

Name	Time	Method

Locations (6): Retina Consultants of Texas - The Woodlands
🇺🇸
Houston, Texas, United States
Retina Consultants of Texas - Bellaire
🇺🇸
Houston, Texas, United States
California Retina Consultants
🇺🇸
Bakersfield, California, United States
Retina Consultants of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Austin Retina Associates
🇺🇸
Austin, Texas, United States
Retina Consultants of Texas - San Antonio
🇺🇸
San Antonio, Texas, United States