Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

Exclusion Criteria

• •Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.
• •Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).
• •Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.
• •Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).
• •Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.
• •Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months.
• •Prior vitrectomy in the study eye.
• •Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded.
• •Intraocular pressure (IOP) of \>22 mmHg in the study eye or use of \>2 antiglaucoma agents (combination agents count as 2 agents) in the study eye.
• •Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection.
• •Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye.
• •Poorly controlled DM.
• •Uncontrolled hypertension
• •Prior treatment with ocriplasminin the study eye within 3 months