Investigational Eye Drop for Wet Age-Related Macular Degeneration Enters Phase 2 Clinical Trial

For an estimated 10% of people living with age-related macular degeneration (AMD), the disease will advance from the more common dry form of AMD to an advanced wet form.¹ Wet AMD, also called neovascular age-related macular degeneration (nAMD), occurs when abnormal, new blood vessels form and leak fluid and/or blood under the central part of the retina, called the macula. This can quickly lead to loss of central vision.

The pharmaceutical company Kyowa Kirin is conducting a Phase 2 clinical trial to evaluate whether an investigational eye drop, called KHK4951, could help people with nAMD.

Clinical trials occur in four stages-called phases-to evaluate the safety and effectiveness of an investigational treatment and see how the body will process a drug. In a Phase 2 clinical trial, investigators determine the right dosage of medication for optimal effectiveness and safety and monitor the drug's journey through the body. KHK4951 is entering its' Phase 2 clinical trial as a treatment for nAMD.

About the Treatment

KHK4951 is an investigational eye drop formulation of tivozanib, a novel vascular endothelial growth factor receptor inhibitor (known as anti-VEGF treatments). The VEGF protein is a common drug target for nAMD, as too much of it promotes the growth and leakage of abnormal vessels in the retina for people with nAMD. Currently, available anti-VEGF treatments are only offered as an eye injection, but KHK4951 is an eye drop designed to potentially block abnormal, new blood vessels from forming and leaking in the back of the eye.

Clinical Trial Eligibility

You may be able to take part in the KHK4951 Phase 2 study if you are 50 years of age or over, have nAMD, and are not currently receiving treatment for nAMD. For eligible participants, the study duration will be up to 56 weeks and include the following stages:

• Screening: up to 4 weeks before pre-study treatment begins, you will be asked to visit your nearest study center for tests to see if you can take part in this study.
• Pre-study treatment*: if the results of the screening tests show you can take part, you will receive three injections of a medication already approved to treat nAMD, called EYLEA® (aflibercept). This part of the study lasts 8 weeks.
• Study period*: After proof of a favorable response the initial aflibercept treatment, you will be assigned to your dosing group to receive KHK4951. This part of the study lasts 44 weeks. During this period, you will instill the investigational eye drop twice daily: one drop in the morning and one drop in the evening.

  • There are three dosing groups that will receive either a small, medium, or larger amount of KHK4951 daily, respectively.

• Follow-up: during the next 4 weeks, you will have assessments either at the study center or via telephone. No investigational eye drop is used during this phase of the Phase 2 clinical trial.

*during the pre-study treatment and study treatment periods, you will visit the study center for tests every 4 weeks.

Study participants can expect the following testing to occur during their participation, including:

• Questions about how nAMD symptoms affect your general health and daily activities
• Physical examination
• Examinations to check your vision and the condition of your eyes
• Collection of samples of your blood and urine
• Electrocardiogram, which records the rate and rhythm of your heart beats
• Measurement of your blood pressure, pulse and body temperature

To learn more about this clinical trial, visit https://clinicaltrials.gov/study/NCT06116890.

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