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Monoclonal Antibodies

KHK4951 for Age-Related Macular Degeneration

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
Active subfoveal MNV (any subtype) or juxtafoveal MNV secondary to AMD with leakage affecting the fovea in the study eye at screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 44 weeks
Awards & highlights

Study Summary

This trial tests a new eye drop to treat a type of age-related vision degeneration.

Who is the study for?
This trial is for adults with active neovascular Age-Related Macular Degeneration (nAMD) affecting the center of their retina. Participants must have certain levels of vision clarity and retinal thickness. Those with extensive eye damage, uncontrolled glaucoma, previous significant eye surgeries or treatments, or other conditions that could affect vision outcomes are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of KHK4951 eye drops compared to Aflibercept injections in treating nAMD. The goal is to see if KHK4951 can improve visual function and reduce abnormal blood vessel growth under the retina.See study design
What are the potential side effects?
While specific side effects for KHK4951 aren't listed, similar treatments often cause eye irritation, redness, discomfort at the injection site (for Aflibercept), potential increase in intraocular pressure, and rarely infection or inflammation inside the eye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eye condition is due to AMD and affects the center of my vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~44 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 44 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 MNV lesion area and total MNV leakage area as measured by FA
Change from baseline in SHRM as measured by SD-OCT
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
5,541 Total Patients Enrolled
Shinsaku KiharaStudy DirectorKyowa Kirin Co., Ltd.
1 Previous Clinical Trials
150 Total Patients Enrolled
Sotaro TakigawaStudy DirectorKyowa Kirin Co., Ltd.
1 Previous Clinical Trials
150 Total Patients Enrolled

Frequently Asked Questions

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

Does the FDA recognize Arm A as a viable treatment option?

"Arm A was assigned a safety rating of 2, as there is evidence to support its relative security, though the efficacy of this treatment has yet to be confirmed."

Answered by AI

In what locations is this investigation being conducted?

"Patients can receive treatment at The Retina Partners in Encino, Florida; Retina Associates of Southern California in Huntington Beach, New mexico; Blue Ocean Clinical Research West in Clearwater, New york and 28 other centers."

Answered by AI

Are there any vacancies left on this clinical trial?

"This trial, which was originally posted on November 1st 2023 and last updated October 31st 2023 is no longer enrolling patients. Despite this, there are currently 170 other trials actively recruiting participants at the moment."

Answered by AI

Who else is applying?

What site did they apply to?
Eye Associates of Pinellas
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried other drugs with little success.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
2024. "Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06116890.
All > Age Related Macular Degeneration > Wet Macular Degeneration
~120 spots leftby Nov 2025
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