Diabetic macular edema is a sight-threatening eye disease that occurs in people with diabetes in which fluid leaks into the macula, the center part of the retina where sharp, straight-forward vision occurs. The fluid makes the macula swell, causing vision to blur.
"All patients with diabetes are at risk of developing diabetic macular edema," Dr. Renata Albrecht of the FDA's Center for Drug Evaluation and Research said in a statement.
Two clinical studies involving 759 patients randomly assigned to receive monthly injections of Lucentis at 0.3 milligrams or 0.5 mg, or no injections during the first 24 months of the studies. After 24 months, all patients received monthly Lucentis either at 0.3 mg or 0.5 mg, Albrecht said.
The studies measured the number of patients who gained vision, as measured on an eye chart. Results showed that between 34 percent and 45 percent of those treated with monthly Lucentis -- ranibizumab injection -- 0.3 mg gained at least three lines of vision compared with 12 percent to 18 percent of those who did not receive an injection.
The most common side effects reported in patients treated with Lucentis include bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; floaters; and increased pressure inside the eye, Albrecht said.
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