Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

Prior treatment

• Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within 16 weeks prior to screening
• Prior treatment with anti-VEGF in the study eye:
  • Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection.
  • Previously treated group (Part A and B), subjects in the previously treated group are excluded if they meet any of the below criteria for the study eye at screening:
  • Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).
  • Time interval between the first anti-VEGF injection and screening is more than 40 weeks.
  • Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.
  • Last injection with aflibercept within 8 weeks prior to screening.
  • Last injection with faricimab or brolucizumab within 12 weeks prior to screening.
  • Prior treatment with SUSVIMO (Port Delivery System) implant is exclusionary.
• Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the study eye.
• Prior treatment with suprachoroidal steroids in the study eye 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 5 years

Lab values

• Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 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 between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters