A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients with Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema (DME)
- Registration Number
- JPRN-jRCT2031230400
- Lead Sponsor
- Takigawa Sotaro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 117
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 micrometre >= CST >= 325 micrometre in the study eye at screening
-HbA1c <= 11 percent at screening
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method