Diabetic Macular Edema (DME)
Conditions
Sponsors
Takigawa Sotaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Voluntary written informed consent to participate in the study -BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening -500 micrometre >= CST >= 325 micrometre in the study eye at screening -HbA1c <= 11 percent at screening
Exclusion criteria
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 within 12 weeks prior to Day 1. - Previous intraocular device implantation except PC-IOL - Previous laser (any type) to the macular area within 12 weeks prior to Day 1. - 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 nDME 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| -The number of aflibercept IVT -Change from baseline in SHRM as measured by SD-OCT -Change from baseline in retinal morphology as measured by SD-OCT -Change from baseline in leakage as measured by FA -Number of participants with adverse events -Serum KHK4951 concentration | — |
Countries
Australia, Japan, South Korea, United States
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed