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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 36 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Secondary outcome measures
Change from baseline in SHRM as measured by SD-OCT
Change from baseline in leakage as measured by FA
Change from baseline in retinal morphology as measured by SD-OCT
+1 more
Other outcome measures
Number of participants with adverse events
Serum KHK4951 concentration

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
2017
Completed Phase 4
~150

Find a Location

Who is running the clinical trial?

Kyowa Kirin, Inc.Lead Sponsor
47 Previous Clinical Trials
5,571 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative taking on new participants?

"Information hosted on clinicaltrials.gov signifies that this study is not presently recruiting patients, despite having been initially posted on November 1st 2023 and updated as recently as October 31st 2023. Despite this trial no longer being open for recruitment, 121 other trials are accepting participants at the moment."

Answered by AI

Has Arm A been granted regulatory clearance by the FDA?

"Arm A's safety was rated a 2 on the scale due to its Phase 2 status, meaning there is some evidence of security but no proof that it will be effective."

Answered by AI

How many locations are participating in this trial?

"Patients can apply to be part of this clinical trial at the Retina Partners in Encino, Florida; Retina Associates of Southern California in Huntington Beach, Maryland; and Retina Consultants of Southern California in Redlands, New mexico as well as 30 other sites."

Answered by AI

Who else is applying?

What site did they apply to?
Ophthalmic Consultants of Long Island
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have macular edema.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
2024. "Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06116916.
All > Macular Edema > Tucson
~100 spots leftby Nov 2025
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