Protocol Number: GR40550
Principal Investigator: Scott Westhouse, D.O.
The purpose of this study is to compare the effects of ranibizumab (medicine that blocks VEGF) when it is delivered by an ocular (eye) implant (also known as the Port Delivery System with ranibizumab or PDS) versus ranibizumab delivered by injections into the eye as a treatment for diabetic macular edema (DME). Ranibizumab is a medicine that blocks VEGF, which in turn slows the growth of and leakage from the damaged blood vessels in your eye. The ocular implant releases ranibizumab continuously (without stopping) over a long period of time into the back of the eye and can be refilled with fresh ranibizumab by the study doctor as needed. The implant releases ranibizumab over time and as a result patients may not need additional eye injections to treat their DME. Patients will either receive the treatment delivered by the ocular implant with refills every 6 months or patients will receive monthly injections of the treatment into the eye. This study will help determine whether ranibizumab delivered continuously through an ocular implant is similar in effectiveness to ranibizumab injections into the eye.