Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema (DME)
- Registration Number
- NCT06116916
- Lead Sponsor
- Kyowa Kirin, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria:<br><br> - Voluntary written informed consent to participate in the study<br><br> - BCVA ETDRS letter score of 73 letters to 35 letters as measured by the ETDRS visual<br> acuity chart in the study eye at screening<br><br> - 500 µm = CST = 325 µm in the study eye at screening<br><br> - HbA1c = 11% at screening<br><br>Exclusion Criteria:<br><br> - Any signs of proliferative diabetic retinopathy in the study eye<br><br> - History of rubeosis in the study eye<br><br> - Uncontrolled glaucoma in the study eye<br><br> - Aphakia or pseudophakia with AC-IOL in the study eye<br><br> - Active intraocular inflammation in the study eye<br><br> - Any current ocular condition for which visual acuity loss would not improve from<br> resolution of macular edema in the study eye<br><br> - History of rhegmatogenous retinal detachment in the study eye<br><br> - Any current or history of ocular disease other than DME that may confound assessment<br> of the macula or affect central vision in the study eye<br><br> - History of the following therapies in the study eye<br><br> - History of vitrectomy surgery, submacular surgery, or other surgical<br> intervention for DME<br><br> - Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids<br><br> - Previous intraocular device implantation except PC-IOL<br><br> - Previous laser (any type) to the macular area<br><br> - Previous panretinal photocoagulation treatment<br><br> - Previous treatment with any IVT anti-VEGF drugs<br><br> - Previous use of Ozurdex® or Iluvien® implant<br><br> - Any current or history of endophthalmitis in either eye<br><br> - History of idiopathic or autoimmune-associated uveitis in either eye<br><br> - Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either<br> eye
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
- Secondary Outcome Measures
Name Time Method 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