leads clinical trials to treat wet age-related macular degeneration

BY MARY BROLLEY

New drug therapies show promise for treatment of macular degeneration

IT CAUSES NO PAIN. Yet the leading cause of vision loss and blindness in those 65 and older in the United States — wet age-related macular degeneration (AMD) — robs people of their sight from the inside out.

Until recently, the disease, which often

appears suddenly, was difficult to treat. But the outlook has improved, thanks to Lucentis, a new drug approved recently by the Food and Drug Administration.

“It’s a devastating disease,”said Dr. David M. Brown, a retinal surgeon at The Methodist Hospital. “Our research team has been working on AMD for a long time.” Clinical trials led by Brown found that Lucentis is very effective in treating wet AMD.

There are two forms of AMD: dry and wet. The dry form refers to damage to the macula (central retina). While all cases begin as the dry form, wet AMD accounts for about 85 percent of all AMD-related blindness and can result in sudden and severe vision loss.

Wet AMD is caused by the growth of abnormal blood vessels that leak fluid and blood under the

macula, causing scar tissue that destroys it. Symptoms include blurred, gray or blank spots in the center of the visual field and distortion that makes edges or lines appear wavy.

“It happens so fast it’s unreal,” said Shirley Smith, who, in 2004, noticed a change overnight in the vision in her left eye. A retired office manager in her early 70s, Smith was treated with the best therapies available at the time, but she still lost 95 percent of the vision in that eye. When she began to have symptoms of wet AMD in the right eye, she agreed to join the Lucentis clinical trial.

Lucentis works by blocking new blood vessel growth and leakiness by binding and inhibiting VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels.

Before treatment, Smith’s vision was 20/200. Within just four days of her first injection, she “started getting more light” into her eye. Now, with monthly Lucentis injections, her vision has stabilizedat 20/60. She calls it her “miracle drug.”

Smith’s experience is not unique. About 90 percent of patients in the trial who received monthly Lucentis injections experienced improved eyesight, and 40 percent of them improved significantly — meaning improvement of three to four lines on a standard eye chart. Eight percent actually experienced a return to 20/20 vision.

This is unprecedented success in treating this increasingly common disease. The National Eye

Institute estimates that there are 1.7 million Americans with the advanced form of AMD and that this prevalence will escalate to 2.95 million by 2020.

Dr. David M. Brown

The FDA approval of Lucentis was based on data from two separate two-year Phase III clinical trials. Of the approximately 1,100 patients who participated in the trials worldwide, Brown and his colleagues enrolled the most patients. Data from several other studies also were included in the FDA submission.

Age-related macular degeneration affects the central part of a person’s vision — that which is crucial for performing daily activities like driving and reading; doing fine work like sewing or needlepoint; and even identifying the faces of loved ones.

Smith must use a magnifying glass to read or sew, but she is able to putter around in her garden — her “little piece of heaven” — daily. She estimates that she spends about three hours a day in her garden. “I’m an outdoor person. I thank God every morning that I can still see,” she said. “The new treatment has done so much for my life.”

She cautions others not to ignore or accept the vision loss brought on by wet AMD, but instead to seek treatment. “It’s not a normal part of aging,” she said.

Brown, who has authored two studies in the New England Journal of Medicine that announced Lucentis’ effectiveness, is happy for his part in the successful clinical trials that led to FDA approval. “The brave patients who participated in our trials helped make this treatment available to the millions of patients affected by AMD,” he said.

“Helping these patients stabilize and often improve their vision was a goal that was unthinkable just a couple of years ago,” he said. “It’s been extremely rewarding to be part of this process.”

Shirley Smith calls Lucentis her “miracle drug.”

To find out more about Lucentis or to obtain a physician referral, call 713.790.3333 or visit www.methodisthealth.com.