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

Inclusion Criteria:

• Voluntary written informed consent to participate in the study

• In Korea, participants must be 19 years or older to be enrolled

• BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visualacuity chart in the study eye at screening

• 500 μm ≥ CST ≥ 325 μm in the study eye at screening

• HbA1c ≤ 11% at screening

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 fromresolution 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 assessmentof 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 surgicalintervention for DME

• Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeksprior 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 biosimilarswithin 12 weeks prior to Day 1. Previously treated patients who received thesemedications more than 12 weeks prior to Day 1 can be enrolled, but the patientsshould 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 eithereye