Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Kyowa Kirin

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Macular Edema (DME)

Treatments: Drug: KHK4951; Drug: Aflibercept Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06116916

4951-003

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
  • 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 2 mg, and their biosimilars
  • Previous treatment with ranibizumab, bevacizumab, aflibercept 2 mg, 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 3 years 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

Arm A

Experimental group

Description:

KHK4951 High dose

Treatment:

Drug: Aflibercept Injection

Drug: KHK4951

Arm B

Experimental group

Description:

KHK4951 Middle dose

Treatment:

Drug: Aflibercept Injection

Drug: KHK4951

Arm C

Experimental group

Description:

KHK4951 Low dose

Treatment:

Drug: Aflibercept Injection

Drug: KHK4951