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

NCT06116916 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-30

No results posted yet for this study

Summary

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

Conditions

  • Diabetic Macular Edema (DME)

Interventions

DRUG

KHK4951

KHK4951 eye drop for 36 weeks until end of the trial

DRUG

Aflibercept Injection

Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sotaro Takigawa · Kyowa Kirin Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2026-08-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116916 on ClinicalTrials.gov