Protocol Number: KS301P106
Principal Investigator: Nathan Pezda, M.D.
The goal of this study is to determine whether KSI-301 is safe and effective as a treatment for moderately severe to severe nonproliferative diabetic retinopathy. KSI-301 is an anti-VEGF drug injected into the eye that is designed to last for a longer time inside the eye. A protein called VEGF (vascular endothelial growth factor) is present inside the eye at excessive levels in people with DR. KSI-301 is a drug that blocks VEGF and is injected into the eye. It is designed to last for a longer time inside the eye compared to other VEGF-blocking medicines. KSI-301 is an anti-VEGF drug injected into the eye that is designed to last for a longer time inside the eye. In this study, KSI-301 will be given every 6 months after a series of initial doses, and changes in DR severity and the rate of development of sight-threatening complications will be compared between people who do or do not receive KSI-301. KSI-301 has been tested in people and in animals and has been shown to be safe and well tolerated so far. KSI-301 is an investigational drug, which means it is a drug that is being tested and has not yet been approved by regulatory authorities, such as the US Food and Drug Administration (FDA).