The trial is taking place at:
S

Strathfield Retina Clinic | Strathfield, Australia

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

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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
  • 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 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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial contacts and locations

85

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Central trial contact

Kyowa Kirin, Inc.

Data sourced from clinicaltrials.gov

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