CAPE: Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Suprachoroidal Triamcinolone acetonide 2.4mg 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
Single suprachoroidal Administration of Triamcinolone acetonide
Other Names:
Device: Semi-automated Suprachoroidal Microcatheter
Ophthalmic Adminstration Device
Other Names:
|
| Experimental: Suprachoroidal Triamcinolone acetonide 4.0 mg 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
Single suprachoroidal Administration of Triamcinolone acetonide
Other Names:
Device: Semi-automated Suprachoroidal Microcatheter
Ophthalmic Adminstration Device
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events [24 Weeks]
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)
- Frequency of adverse device effects and frequency of serious adverse device effects [24 Weeks]
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)
Eligibility Criteria
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 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:
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Macular edema is considered due to a cause other than diabetes mellitus in the study eye.
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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.
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Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye.
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Active malignancy or history of malignancy within the past five years.
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Prior intravitreal (IVT) treatment with anti-Vascular endothelial growth factor (VEGF) in the study eye: last injection within four weeks, before screening
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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.
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Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary.
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Prior treatment with suprachoroidal steroids is exclusionary.
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Uncontrolled diabetes with a hemoglobin A1c (HbA1c) > 12% or any other uncontrolled systemic disease at screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oxular Limited
Investigators
- Study Director: Friedrich Asmus, MD, Oxular Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OXUCT-103 - CAPE
- 2022-001533-37