Protocol Number: KS301P103
Principal Investigator: Scott Westhouse, D.O.
The purpose of this Phase 3 study is to determine whether an investigational drug called KSI-301 is safe and effective in the treatment of macular edema secondary to retinal vein occlusion, compared with the standard treatment aflibercept. The standard treatment for macular edema secondary to vein occlusion involves eye injections every month to decrease the swelling of the retina. These injections work by blocking a protein in the eye called vascular endothelial growth factor (VEGF). When there is too much VEGF inside the eye because of retinal vein occlusion, swelling can occur. KSI-301, developed by Kodiak Sciences Inc., is designed to decrease fluid leakage and swelling in the retina by blocking VEGF. KSI-301 may last longer in the eye compared to the standard injection treatments (i.e., aflibercept) and thus require fewer injections over time for patients. In this study, the standard dose of KSI-301 will be compared to the standard dose of aflibercept. Participants are randomly assigned to receive either KSI-301 or aflibercept. There is an equal number of patients in each arm of the study.