* 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
Clareo Health | Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
