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

Description

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

Conditions

Diabetic Macular Edema (DME)

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Diabetic Macular Edema (DME)
Intervention / Treatment

-

Contacts and Locations

Mesa

Barnet Dulaney Perkins Eye Center - Phoenix, Mesa, Arizona, United States, 85206

Tucson

Retina Associates Southwest, P.C., Tucson, Arizona, United States, 85710

Arcadia

Win Retina, Arcadia, California, United States, 91006

Beverly Hills

Retina Vitreous Associates Medical Group, Beverly Hills, California, United States, 90211

Encino

The Retina Partners, Encino, California, United States, 91436

Huntington Beach

Salehi Retina Institute, Inc, Huntington Beach, California, United States, 92647

Pasadena

California Eye Specialists Medical Group Inc, Pasadena, California, United States, 91107

Redlands

Retina Consultants of Southern California, Redlands, California, United States, 92374

Colorado Springs

Retina Consultants of Southern CO, Colorado Springs, Colorado, United States, 80909

Clearwater

Blue Ocean Clinical Research West, Clearwater, Florida, United States, 33761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kyowa Kirin, Inc.,

Sotaro Takigawa, STUDY_DIRECTOR, Kyowa Kirin Co., Ltd.

Study Record Dates

2025-12