What is the mechanism of action of this treatment?

The most common treatments for Age-Related Macular Degeneration (AMD) are anti-VEGF agents, which inhibit the action of vascular endothelial growth factor (VEGF). VEGF is a protein that stimulates the growth of abnormal blood vessels in the retina, leading to fluid leakage, hemorrhage, and scar tissue formation. By blocking VEGF, these treatments reduce these harmful effects, thereby preserving vision and preventing further deterioration. This is crucial for AMD patients as it helps maintain their visual function and quality of life, allowing them to perform daily activities with greater independence.

What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD), particularly anti-VEGF agents like ranibizumab, bevacizumab, and aflibercept, are associated with several side effects. These treatments, typically administered via intravitreal injections, can cause eye pain, increased intraocular pressure, vitreous floaters, and inflammation. Rare but serious complications include retinal detachment, endophthalmitis (an infection inside the eye), and cataracts. Patients should be monitored closely for these adverse effects to manage them promptly.

What prior FDA approvals exist?

The FDA has approved several anti-VEGF agents for the treatment of neovascular Age-Related Macular Degeneration (AMD). These include ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin), which are designed to inhibit vascular endothelial growth factor (VEGF) and prevent abnormal blood vessel growth in the retina. These treatments have been shown to reduce vision loss and, in some cases, improve vision in patients with neovascular AMD.

What other types of research exist?

Promising novel alternatives to KHK4951 eye drops for AMD patients in 2024 include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown positive results in clinical trials. 2) Brolucizumab, a single-chain antibody fragment that offers longer dosing intervals. 3) Gene therapy approaches like RGX-314, which aims to provide sustained anti-VEGF expression. 4) Port delivery systems (PDS) with ranibizumab, designed for continuous drug delivery and reducing the frequency of intravitreal injections.

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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

Must not have

Subretinal hemorrhage, fibrosis, or atrophy of > 50% of the total lesion area and/or that involves the fovea in the study eye

Uncontrolled glaucoma in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing special eye drops called KHK4951 to help people with a vision problem known as nAMD. The drops aim to improve vision by addressing abnormal blood vessels in the eye.

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.

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.

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

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My eye condition is due to AMD and affects the center of my vision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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More than half of the lesion in my eye involves bleeding, scarring, or tissue loss and affects the central vision area.

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My glaucoma in one eye is not under control.

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I have active inflammation in my eye.

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My vision loss won't improve even if the swelling in my eye is treated.

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I have no eye conditions affecting my central vision other than nAMD.

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I have used corticosteroids around or in my eye.

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I have had laser treatment on my macula.

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I have been treated with IVT anti-VEGF drugs before.

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I have never had an eye infection called endophthalmitis.

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I have had uveitis without a known cause or due to an autoimmune condition.

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I have had eye surgery for AMD.

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I have had treatments like Visudyne, radiation, or laser therapy for my eye condition.

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I do not have an active eye infection.

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I have had a retinal detachment in the eye being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Age-Related Macular Degeneration (AMD) are anti-VEGF agents, which inhibit the action of vascular endothelial growth factor (VEGF). VEGF is a protein that stimulates the growth of abnormal blood vessels in the retina, leading to fluid leakage, hemorrhage, and scar tissue formation. By blocking VEGF, these treatments reduce these harmful effects, thereby preserving vision and preventing further deterioration. This is crucial for AMD patients as it helps maintain their visual function and quality of life, allowing them to perform daily activities with greater independence.