New eye injection shows promise for diabetic vision loss

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters 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 16 weeks prior to screening * Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye * Prior treatment with anti-VEGF in the study eye: 1. Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection. 2. 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: 1. Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility). 2. Time interval between the first anti-VEGF injection and screening is more than 40 weeks. 3. Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening. 4. Last injection with aflibercept within 8 weeks prior to screening. 5. Last injection with faricimab or brolucizumab within 12 weeks prior to screening. 6. 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. * Active malignancy or history of malignancy within the past 5 years * Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any other uncontrolled systemic disease at screening.