Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Prior treatment

• Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within sixteen (16) weeks prior to screening.
• 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.

Other illness

• 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
• Active malignancy or history of malignancy within the past five years.

Lab values

• Uncontrolled diabetes with a hemoglobin A1c (HbA1c) \> 12% or any other uncontrolled systemic disease at screening.

Other

• Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye.

• 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