A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
The purpose of this study is to evaluate 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) to treat Diabetic Retinopathy (DR) versus treating by routine diagnostic vision tests, photographs of the eye, and eye examination to monitor DR. The ocular implant releases ranibizumab continuously (without stopping) over a long period of time into the back of a patient's eye. When necessary, the contents of the implant can be exchanged with fresh ranibizumab by the study doctor in a refill study procedure (also known as refill-exchange). Because the implant continuously releases ranibizumab over time, a patient may not need additional eye injections for their DR between refills. This study will help determine whether ranibizumab delivered continuously through an ocular implant is a better treatment than observation with clinical monitoring for patients with DR.
DR is a complication of diabetes that causes damage to the retina. The primary cause of DR is diabetes, a condition that interferes with the body's ability to use and store glucose (sugar). Over time, too much sugar in the blood can damage the small blood vessels in the retina causing them to leak blood and other fluid, or to become blocked completely. Symptoms of DR may included blurred or double vision, difficulty reading or seeing well at night, seeing spots or floaters in your vision, having a dark shadow in your field of vision, and eye pain or pressure. In some cases, patients may have DR but have no symptions. Ranibizumab is a medicine that blocks vascular endothelial growth factor (VEGF), which in turns slows the growth of and leakage from the damaged blood vessels in the eye.
If you would like more information on this study, please click on the link at the top of the page or go to www.clinicaltrials.gov.