This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab (PDS) in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab
The purpose of this study is to compare the effects, good or bad, of ranibizumab 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 treatment for diabetic macular edema (DME). 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. Because the implant continuously releases ranibizumab over time, a patient may not need additional eye injections to treat their DME. This study will help determine whether ranibizumab delivered continuously through an ocular implant is similiar in effectiveness to ranibizumab injections into the eye for treating patients with DME.
DME, a long-lasting condition, is the most common cause of vision loss amoung people with diabetes and causes problems in vision such as blurred or wavy vision and colors that appear to be washed out. It is caused by damage to blood vessels in the retina that causes the vessels to leak blood or fluid into the macula. DME causes the macula to swell, leading to blurred or wavy vision. A protein called vascular endothelial growth factor (VEGF) is involved in the development and leakiness of damaged blood vessels, which leak blood or flood in the macula in patients with DME. Ranibizumab is a medicine that blocks VEGF, which in turns slows the growth of and leakage from the damaged blood vessels in the eye.
For more information on the study, please click on the title link above.