Overview
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Eligibility
Inclusion Criteria:
- Voluntary written informed consent to participate in the study
- BCVA ETDRS letter score of 73 letters to 35 letters as measured by the ETDRS visual acuity 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 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
- Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids
- Previous intraocular device implantation except PC-IOL
- Previous laser (any type) to the macular area
- Previous panretinal photocoagulation treatment
- Previous treatment with any IVT anti-VEGF drugs
- 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