NCT06116916
Active, not recruiting
Phase 2
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema
ConditionsDiabetic Macular Edema (DME)
Overview
- Phase
- Phase 2
- Intervention
- KHK4951
- Conditions
- Diabetic Macular Edema (DME)
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 150
- Locations
- 87
- Primary Endpoint
- Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntary written informed consent to participate in the study
- •In Korea, participants must be 19 years or older to be enrolled
- •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 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
Arms & Interventions
Arm A
KHK4951 High dose
Intervention: KHK4951
Arm A
KHK4951 High dose
Intervention: Aflibercept Injection
Arm B
KHK4951 Middle dose
Intervention: KHK4951
Arm B
KHK4951 Middle dose
Intervention: Aflibercept Injection
Arm C
KHK4951 Low dose
Intervention: KHK4951
Arm C
KHK4951 Low dose
Intervention: Aflibercept Injection
Outcomes
Primary Outcomes
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Time Frame: For 36 weeks until the end of the trial
Secondary Outcomes
- The number of aflibercept IVT(For 36 weeks until the end of the trial)
- Change from baseline in leakage as measured by FA(36 Weeks)
- Change from baseline in SHRM as measured by SD-OCT(36 Weeks)
- Change from baseline in retinal morphology as measured by SD-OCT(36 Weeks)
Study Sites (87)
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