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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
Single suprachoroidal Administration of Triamcinolone acetonide
Ophthalmic Adminstration Device
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 - The Woodlands
Houston, Texas, United States
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
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)
Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
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)
Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
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Retina Consultants of Texas - Bellaire
Houston, Texas, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States