Marion Kleinfeld's life was rapidly growing dark.
The 78-year-old Delray Beach grandmother was legally blind in her right eye and one morning awoke to discover she couldn't read the paper with her good eye. "It was a sudden thing, and so scary, a complete nightmare," Kleinfeld said.
Kleinfeld learned she was among an estimated 1.8 million Americans suffering from age-related macular degeneration. As Baby Boomers age, that number is projected to reach 2.9 million in the next 15 years. The leading cause of blindness in those 60 and older, macular degeneration blurs the sharp, central vision and affects the part of the eye needed to see fine detail.
Kleinfeld, however, got lucky. Her doctors, Mark Michels and Adrian Laviña, retina specialists in Palm Beach County, are among a group of physicians nationwide testing Lucentis, a new drug developed by Genentech Inc., a publicly traded biotech company in San Francisco.
After she was diagnosed, Kleinfeld was added to the study.
Cigarette smoking, overexposure to ultraviolet light and a diet high in fat are thought to contribute to the disease. In addition, women are more likely to develop it.
The odds of developing the eye disorder go up as a person ages. The rate is about 18 percent among those 70 to 74, but shoots up to 47 percent among those 85 and older.
After 20 treatments, Kleinfeld's vision improved so much that she can now crochet, read, sew and once again see the faces of her five grandchildren.
"It's so exciting because for the first time in a phase III clinical trial we are not measuring success by less loss of vision, but by improvement of vision," Michels said.
The eye is numbed and the drug is injected once a month for 24 months.
"When we started doing this, I thought there was no way these people would put up with having a needle in their eye every month," Michels said. "But some of these patients are doing extraordinarily well; I am sure they would do it every two weeks if that's what it took."
Kleinfeld agrees. "I am so grateful, who cares if it hurts a little," she said.
In May, Genentech announced that approximately 95 percent of 716 patients in clinical trials nationwide either maintained or had improved vision using Lucentis. The company will present those findings today at a meeting of the American Society of Retina Specialists in Canada.
In the clinical trial in which Kleinfeld is participating, patients either are given a dose of the drug Lucentis or treated with photodynamic therapy, which uses a low-energy laser. Photodynamic therapy slows the progression of the disease, but has not been shown to stop or reverse it. The patient isn't told what they are getting.
"That's part of the game, we can't talk about who is getting what," said Michels, whose practice has 25 patients in the study. Half, he said, are doing remarkably well.
Although Kleinfeld doesn't know if she is getting Lucentis, she suspects she is after gaining improvement within weeks of starting treatment. "After the first month I started to see again," she said.
Last year, the Food and Drug Administration approved another drug, Macugen, to treat macular degeneration.
Dr. Philip Rosenfeld, associate professor of ophthalmology at the University of Miami's Bascom Palmer Eye Institute, has been testing Macugen and Lucentis. "Every drug we have been told about has been the next best thing for treatment of macular degeneration.
We need to get both drugs on the market so we can get them side by side," Rosenfeld said.
It may be a while before patients have that choice. More studies are in the works, the results of which are not expected until later this year and early next year.
susan_miller@pbpost.com
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