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KHK4951 for Diabetic Macular Edema

Phase 2
Recruiting
Research Sponsored by Kyowa Kirin, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if an eye drop can help treat people with diabetic macular edema (DME).

Who is the study for?
This trial is for patients with Diabetic Macular Edema (DME) who have a certain level of central retinal thickness and visual acuity, controlled diabetes (HbA1c ≤ 11%), and no history of severe eye conditions or treatments that could affect the study's outcome.
What is being tested?
The trial is testing KHK4951 eye drops against Aflibercept injections to see which one is better at treating DME. Patients will be closely monitored to measure the effectiveness and safety of the KHK4951 treatment.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions related to eye medications such as discomfort, redness, irritation, or more serious complications if adverse events occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment2 Interventions
KHK4951 Low dose
Group II: Arm BExperimental Treatment2 Interventions
KHK4951 Middle dose
Group III: Arm AExperimental Treatment2 Interventions
KHK4951 High dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept Injection
2019
Completed Phase 4
~180

Find a Location

Who is running the clinical trial?

Kyowa Kirin, Inc.Lead Sponsor
48 Previous Clinical Trials
5,595 Total Patients Enrolled
Shinsaku KiharaStudy DirectorKyowa Kirin Co., Ltd.
1 Previous Clinical Trials
180 Total Patients Enrolled
Sotaro TakigawaStudy DirectorKyowa Kirin Co., Ltd.
1 Previous Clinical Trials
180 Total Patients Enrolled
~79 spots leftby Nov 2025
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