Protocol Number: KS301P104
Principal Investigator: Scott Westhouse, D.O.
This is a Phase 3 study of an investigational drug called KSI-301, being developed by Kodiak Sciences, Inc, for the possible treatment of patients with decreased vision associated with retinal vascular disorders such as diabetic macular edema. The purpose of this study is to determine whether KSI-301 is safe and effective in the treatment of diabetic macular edema compared with the standard of care treatment using the drug aflibercept. Like aflibercept, KSI-301 is designed to decrease fluid leakage and swelling of the retina by blocking VEGF. VEGF is a protein in the eye called vascular endothelial growth factor. When there is too much VEGF inside the eye because of damage to the retina from diabetes, swelling and bleeding can occur resulting in vision loss. KSI-301 may last longer in the eye compared to the standard injection treatment using aflibercept and thus fewer injections of KSI-301 may be needed over time by patients. Patients will be randomly assigned to two arms in this study - one group will receive KSI-301 while the other will receive aflibercept. Each group will have 225 participants. Both KSI-301 and aflibercept are given by injection into the eye by an ophthalmologist. This study is double-masked, meaning that neither the patient nor the masked doctor knows which medication is being used.