Following a three-year year clinical study at Retina Health Center and other participating eye centers around the country, the FDA has approved the use of the injectable drug Lucentis for the treatment of diabetic macular edema. Diabetic macular edema occurs when fluid accumulates on or under the macular (the center of the retina) and causes it to thicken or swell. As swelling develops, blurring occurs and vision loss may progress over time.
Until now, there has been no approved drug to treat diabetic macular edema. For the past 30 years, the condition has been treated with laser surgery with minimal reports of improvements in vision or with unapproved drugs such as Avastin or Triamcinolone.
Diagnosed more than 12 years ago with diabetic macular degeneration, Fort Myers resident Jay Goldman has experienced significant improvement in his vision since participating in the three-year clinical study for Lucentis at Retina Health Center.
“I’m an avid reader and musician,” says Goldman. “But as my symptoms progressed, I could no longer read a book, play music or work on the computer. My vision was distorted and I was experiencing pain in my eyes. Following the Lucentis injections, I’m able to see and read clearly again. The improvements are remarkable.”
The approval is based on results of two randomized, double-blind studies involving more than 750 patients. Patients in the study received a monthly injection of 0.5 mg or 0.3 mg of Lucentis or a placebo for 24 months, and were followed for 36 months. Patients who received Lucentis improved their eye chart test scores by at least 15 letters after 24 months of treatment. In addition, 54 percent of patients receiving the lower dose, and 62 percent of those on the higher dose achieved 20/40 vision or better. Lucentis is already approved to treat age-related macular degeneration and retinal vein occlusion.
For more information on the latest studies or to make an appointment, call 239-337-3337 in Fort Myers or 239-793-5200 in Naples.