A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients with Diabetic Macular Edema

JRCT ID: jRCT2031230400

Registered date:16/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetic Macular Edema (DME)
• Date of first enrollment: 22/11/2023
• Target sample size: 117
• Countries of recruitment: United States,Japan,South Korea,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

-KHK4951 eye drop
-Aflibercept intraviteral injection (IVT)

Outcome(s)

• Primary Outcome: Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2mg, and their biosimilars
-Previous treatment with ranibizumab, bevacizumab, aflibercept 2mg, or their biosimilars within 12 weeks before being enrolled to the study.If a previously treated patient is enrolled, the patient should be diagnosed with DME within 3years before being enrolled to the study.
-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

Related Information

• Primary Sponsor: Takigawa Sotaro
• Secondary ID(s): NCT06116916