Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema

Exclusion Criteria

• •Patient with history of intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye \<90 days from baseline
• •Patient with history of intraocular corticosteroids including dexamethasone intravitreal implants during the 6 month period prior to baseline. Any prior use of fluocinolone acetonide intravitreal implant (Iluvien) is prohibited regardless of timing
• •Laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline.
• •High risk proliferative diabetic retinopathy
• •Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C ≥ 12% at screening.
• •Any progressive disease of the retina in the study eye (e.g. uveitis,rod-cone dystrophy) or optic nerve
• •Area of macular retinal ischemia (as measured by the foveal avascular zone) ≥ 1000 μm.
• •Active intraocular inflammation (graded as trace or above) or active intraocular infection in either eye.
• •Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin \<10 g/dL for women and \<11 g/dL for men.