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

This is an interventional treatment trial for Diabetic Macular Edema Read More

Inclusion Criteria:

• Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).
• BCVA of ≥19 letters (~20/400) and ≤73 letters (~20/40) in the study eye and ≥34 letters(~20/200 or better) in the fellow eye.
• Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men
• Subjects first anti-VEGF injection in the study eye occurred ≤36 months.
• Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.
• The last anti-VEGF injection in the study eye is ≥ 8 weeks.

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