Diabetic Macular Edema Clinical Trial
— CAPEOfficial title:
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
Verified date | February 2024 |
Source | Oxular Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Austin Retina Associates | Austin | Texas |
United States | California Retina Consultants | Bakersfield | California |
United States | Retina Consultants of Texas - Bellaire | Houston | Texas |
United States | Retina Consultants of Texas - The Woodlands | Houston | Texas |
United States | Retina Consultants of Minnesota | Minneapolis | Minnesota |
United States | Retina Consultants of Texas - San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Oxular Limited |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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