New Therapies for Wet Macular Degeneration
(Reader's Digest, September, 2002)

Boston eye specialist, Jeffrey Heier, has been testing a drug that has shown promise in treating "wet" age-related Macular Degeneration. The wet form of the disease - caused by leaking blood vessels under the retina - strikes only 10 percent of the estimated 9 million Americans who have or may be developing Macular Degeneration, but accounts for up to 90 percent of the blindness the disease causes.
Nick Fairfield, a 60-year old lobsterman and waterfowl carver from Annisquam, Massachusetts who was diagnosed with wet Macular Degeneration, would be among a select number -- only a few dozen in the world - to try rhuFab, a new drug developed by Genentech, a San Francisco-based biotechnology company. Fairfield's eye was sprouting abnormal blood vessels. In the center of his retina, a cluster of light-sensitive cells called the Macula was being invaded by malformed capillaries. As they bled and leaked fluids, the vessels were literally lifting up Fairfield's Macula, much like bubbling wallpaper in a damp room. The Macula controls straight ahead vision, fine detail, and color perception. People with wet Macular Degeneration often cannot read, write, drive, watch tv, even recognize faces. Fairfield watched a growing black hole appear on the page as he tried to read a newspaper, and on the road as he tried to drive.
For doctors, diagnosing and treating the disease is a race against time. "If you can get rid of the blister quickly, you have a better chance of keeping what vision you've got," says Steven Schwartz, chief of the retina division at UCLA's Jules Stein Eye Institute. "The damage can happen in a day, even in a matter of hours. Just a few drops of fluid in the right place can give you large distortion in your central vision."
By late February, when Fairfield was scheduled to begin the experimental regimen, he was so desperate that the treatment - a needle filled with serum injected directly into the eyeball - was no longer daunting. Heier first numbed and dilated Fairfield's left eye with anesthetic drops, then injected a powerful local anesthetic into the eye. Heier then injected rhuFab into the vitreous gel that fills the eyeball. "There was a prick, and definitely some uncomfortableness, but not huge pain," says Fairfield. The effect was mesmerizing. "When the second needle went in, it was like the ocean washing over your eye. It was like being underwater." The drug was swimming through vitreous fluid toward the retina lining the back wall of his eye.
RhuFab is one of several competing new drugs designed to stop Macular Degeneration before the scar forms. Called anti-neovasculars, they take aim at the body's prime stimulator of blood vessel growth, a protein called vascular endothelial growth factor. Ordinarily, VEGF is a healer, repairing injured tissue throughout the body. In wet Macular Degeneration VEGF goes haywire, triggering growth of the oozing blood vessels.
Two new drugs - Genentech's rhuFab and Eyetech's Macugen - scour the eye for free floating VEGF, bind to it and neutralize it," says Schwartz, who is testing several of the new drugs. "It seems to stop the growth of these blood vessels, and the leakage."
According to preliminary reports, the drugs may go further. "The new blood vessels apparently disappear," says Frederick Ferris, clinical research director of the National Eye Institute. "It's really exciting if it's true, because it holds the possibility of not having to inject into a person's eye for the rest of their life. If you could do it three or four times and that's it - that would be remarkable."
Initial results have been encouraging. Of the 53 patients who've received four monthly injections of rhuFab, 14 have recovered much of their lost vision - three lines or more on an eye chart. Thirty-six others were able to stave off further vision loss. Three patients were not helped. The only side effects were redness and irritation in the treated eye, which lasts for a few days. Macugen restored vision to one in four patients in a 36-person trial. Alcon is testing another anti-neovascular drug, a steroid called anecortave acetate. Injected behind the eye every 6 months, it has also shown promising results. Experts warn that only a tiny number of patients were enrolled in the trials and their progress was followed for a year or less. Until larger and longer trials are completed in the next few years, scientists won't know if the drugs are truly safe or effective. "The field is littered with treatments that seemed promising in the short term but in the long term don't seem to make a big difference. The potential risks associated with injections include retinal detachment and infection. No one really knows the lasting dangers of repeatedly poking a person in the eye with a needle," says Ferris.
Nick Fairfield was one of the lucky ones. Within four days of the first injection, he could discern the blinking red light on the Annisquam River tower. Within a month, he could identify features on a television weather map. "I'm seeing again, and that's just incredible," he says.

(For more information on the progress of clinical trials with rhuFab, call 888-662-6728).

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