The U.S. Food and Drug Administration has approved Lucentis to treat diabetic macular edema, an eye disease that occurs in people with diabetes. Along with good diabetic blood sugar control, Lucentis is an injection given by a health professional once a month that can treat the symptoms of this disease and restore some vision.
Diabetes (type 1 and type 2) affects 26 million people in the United States and is the leading cause of blindness among people ages 20 to 74. All diabetes patients are at risk for diabetic macular edema (DME). DME is a condition affecting the macula, the center part of the retina. Fluid leaks into the macula causing it to swell and vision to blur. As of 2010, a reported 3.9 million people diagnosed with diabetes had trouble with their vision. The approval of Lucentis is a major development for those people who suffer from DME as a complication of diabetes.
Two clinical studies were done to test the safety and efficiency of Lucentis for DME treatment. A group of 759 patients were randomly assigned to receive injections of Lucentis at 0.3 mg or 0.5 mg, or no injections for 24 months. After 24 months, all participants received Lucentis at 0.3 mg or 0.5 mg monthly.
During the study, participants’ gained vision was measured using an eye chart. Findings showed 34 to 45 percent of those treated, using 0.3 mg of Lucentis, gained 3 lines of vision on the eye chart. The 0.5 mg Lucentis group showed no additional benefit. Side effects that were found include: bleeding of the conjunctiva, eye pain, floaters, and intraocular pressure.
Lucentis had been approved in the past to treat macular edema following retinal vein occlusion, a blockage of small veins that carry blood away from the retina, and causes fluid to leak into the macula. It was also approved for wet age-related macular degeneration, where abnormal blood vessels grow and leak fluid into the macula.
Diabetic macular edema – Fluid and protein collects on or under the macula causing it to swell and vision to blur
Written by Kelly Fitzgerald