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HOBE SOUND - Alice Rinaldi remembers when her vision began to fail less than two years ago, how she would look at any printed word and its middle letters would disappear from the page.
Born partially blind in her left eye, the 75-year-old was "terribly worried" she was going to lose sight in her right eye, too. Rinaldi was diagnosed with age-related macular degeneration. It is the leading cause of blindness for people over the age of 60,and the National Eye Institute estimates that the condition affects 1.6 million Americans 40 and older.
Rinaldi had to quit driving a car and faced the prospect of losing her independence.
She decided to participate in the clinical trial for a new drug that her ophthalmologist, Dr. Adrian Laviña, thought had potential to help her.
Such trials typically administer a placebo to some of the subjects without their knowledge, in order to form a control group. But there is no doubt in Rinaldi's mind that she got the real medicine.
"I already know that, because I improved so much," said Rinaldi, who recently started driving once again through the streets of her tight-knit neighborhood.
"The neighbors were out there applauding, 'You didn't hit anything, Alice!'" she laughed.
The drug is called ranibizumab, trademarked Lucentis by San Francisco-based Genentech, which is doing nationwide clinical trials. The trial in which Rinaldi is participating is now closed to new recruits, but Genentech spokesperson Dawn Kalmar said enrollment has begun in a new trial that will administer Lucentis to everyone participating.
The company recently announced preliminary data from the trial in which Rinaldi participated that showed approximately 95 percent of patients treated with Lucentis maintained or improved vision after one year.
Genentech plans to file for Food and Drug Administration approval of the drug in December and the company hopes to have it on the market sometime in 2006, Kalmar said.
Lucentis was developed to treat the so-called wet variety of macular degeneration, in which blood vessels grow under the retina. They leak and form scars on the macula, the central area of the retina, Laviña explained, causing profound vision loss. Patients suffering from the condition often lose the ability to read or recognize faces.
Other drugs and therapies used to treat the condition slow down loss of eyesight.
"You'd still get worse, just less rapidly," Laviña said. |