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

Phase 2

Recruiting

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Drug: KHK4951; Drug: Aflibercept Injection

• Registration Number: NCT06116916
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-03
• Study Start: 2024-01-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2026-08-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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
  • Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
  • Previous intraocular device implantation except PC-IOL
  • Laser (any type) to the macular area within 12 weeks prior to Day 1
  • Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
  • Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
  • Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with DME within 3 years prior to Day 1
  • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	KHK4951	KHK4951 Middle dose
Arm B	Aflibercept Injection	KHK4951 Middle dose
Arm C	KHK4951	KHK4951 Low dose
Arm C	Aflibercept Injection	KHK4951 Low dose
Arm A	Aflibercept Injection	KHK4951 High dose
Arm A	KHK4951	KHK4951 High dose

Primary Outcome Measures

Name	Time	Method
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline	For 36 weeks until the end of the trial

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (87)

Barnet Dulaney Perkins Eye Center - Phoenix; 🇺🇸 Mesa, Arizona, United States

Retina Associates Southwest, P.C.; 🇺🇸 Tucson, Arizona, United States

Win Retina; 🇺🇸 Arcadia, California, United States

Retina Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

The Retina Partners; 🇺🇸 Encino, California, United States

Salehi Retina Institute, Inc; 🇺🇸 Huntington Beach, California, United States

California Eye Specialists Medical Group Inc; 🇺🇸 Pasadena, California, United States

Retina Consultants of Southern California; 🇺🇸 Redlands, California, United States

Retina Consultants of Southern CO; 🇺🇸 Colorado Springs, Colorado, United States

Blue Ocean Clinical Research West; 🇺🇸 Clearwater, Florida, United States

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