Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Exclusion Criteria

• •Any signs of proliferative diabetic retinopathy in the study eye
• •History of rubeosis in the study eye
• •Uncontrolled glaucoma in the study eye
• •Aphakia or pseudophakia with AC-IOL in the study eye
• •Active intraocular inflammation in the study eye
• •Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
• •History of rhegmatogenous retinal detachment in the study eye
• •Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
• •History of the following therapies in the study eye
• •* History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME
• •* Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
• •* Previous intraocular device implantation except PC-IOL
• •* Laser (any type) to the macular area within 12 weeks prior to Day 1
• •* Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
• •* Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
• •* Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with DME within 3 years prior to Day 1
• •* Previous use of Ozurdex® or Iluvien® implant
• •Any current or history of endophthalmitis in either eye
• •History of idiopathic or autoimmune-associated uveitis in either eye
• •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye