Cerulea Clinical Trials

Science and Research

Kyowa Kirin AMD

A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients with Neovascular Age-Related Macular Degeneration.

Overview

The Kyowa Kirin AMD trial is testing a new potential treatment for Neovascular AMD (nAMD) also known as Wet AMD. nAMD is a prevalent, progressive retinal eye disease that is characterised by new blood vessel formation in the choroid (a layer of tissue in the back of the eye that is filled with blood vessels).

Leaking of fluid from these new blood vessels in the eye may result in loss of vision.

Vascular Endothelial Growth Factor (VEGF) is a protein that upon activation plays a significant role in this new blood vessel formation.

The Kyowa Kirin AMD study is testing a new treatment called KHK4951, which is a topical eye drop formulation of tivozanib, a novel VEGFR inhibitor.

KHK4951 is expected to stop the activation of the VEGF receptor (called anti VEGF treatment) and thus block new blood vessel formation.

By slowing and preventing new blood vessels and the leaking fluid from these new vessels, this will help prevent the progression of diseases such as nAMD.

This study will assess the efficacy and safety of KHK4951 in the potential treatment for nAMD.

KHK4951 is not approved for the treatment of nAMD [or any other condition] in Australia therefore it is an experimental treatment in this study.

This study also uses aflibercept (eye injection) as the treatment before starting KHK4951 eye drop treatment, as well as rescue treatment, which means that aflibercept may be used to help your nAMD if KHK4951 is not helping your condition and if it is deemed necessary by your study doctor.

Aflibercept is another anti-VEGF treatment approved by regulatory health agencies worldwide for the treatment of nAMD and other retinal eye diseases.

As part of this study, suitable participants will be screened to determine their eligibility.

If eligible, participants will be randomised to one of 3 treatment arms consisting of different dosages of KHK4951.

The study runs for 12 months and would require participants to use the study eye drops daily.

For further information about this study please contact Cerulea on (03) 86385300 or email info@ceruleaclinicaltrials.org.au.

  • Principal Investigator
Associate Professor Sanj Wickremasinghe

Learn more

View this study on ClinicalTrials.gov

See the ClinicalTrials.gov database listing for more detailed information about this study.