Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxular Limited
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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:

• 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.