Lexington, KY - "I probably wouldn't have wanted to live, to be honest with you." That's how Connie Rhodus describes what she would have felt spending the rest of her life without her sight. Years of traditional laser treatment had done little to stop the progression of Rhodus' vision loss resulting from her type 2 diabetes. And she needed her vision - not only to accurately administer her insulin injections three times a day, but to care for her 28-year-old son, who is disabled and battling cancer.
She was gradually losing the simple pleasure of reading, finding it increasingly difficult to drive a car and, in short, facing a dismal future. Then she was offered an opportunity by Thomas Stone that would change her life and help others.
Stone is an ophthalmologist and partner with Lexington's Retina Associates of Kentucky, one of 52 clinical sites funded by the National Institutes of Health to participate in a study for a new drug called ranibizumab, or Lucentis. Lucentis has been used for years in treating age-related degeneration of the eye's macula (located in the center of the retina). The current clinical trial, which began in June 2008, was focused on using the drug for diabetic-related macular degeneration.
The drug is injected directly into the eye, where it stops leakage of blood vessels near the center of the retina, which can cause the retinal tissues to swell, leading to vision loss or blindness if untreated. The trial study included 691 people nationwide - 27 from Stone's clinic - who had been diagnosed with type 1 or 2 diabetes, were in their early 60s, and suffered from diabetic macular edema, or damage to the retina.
Like the more than 23 million Americans and approximately 324,000 Kentuckians diagnosed with diabetes, Rhodus knew the odds of losing her eyesight were pretty high, as diabetes is the leading cause of acquired cases of blindness. Consequently, Rhodus didn't hesitate to become one of Stone's test subjects.
"Somebody had to do it," she said, "and I felt I could help others by participating."
Three years later, Rhodus is literally seeing good results. According to the published results from the drug's manufacturer, Genentech, 50 percent of patients who received Lucentis in combination with laser treatments had substantial improvement in vision. This is compared to 28 percent who experienced improved vision with laser treatment alone. The results have been similar for the first and second years of the clinical trial.
In Rhodus' case, her right eye, which received the Lucentis injections, along with the laser treatments, has improved from 20-60 to almost 20-20. Her left eye, which received only laser treatments during the same period, stabilized but has stayed at 20-40.
Stone said he is excited about the promising results he's had with Lucentis.
"You can't argue with the data," Stone said. "It's dramatic. We are seeing more people helped - and helped more."
It will probably be a year or two before the drug is widely available and affordable, however. While Lucentis was approved by the FDA in 2006 for treating age-related macular degeneration, it is not yet approved for use in diabetic-related eye problems. That approval will come only after the data from the current third and final phase of the clinical trial is thoroughly analyzed. Until that time, insurance companies will not provide coverage for the drug, which can cost as much as $2,000 per injection.
Stone predicted that Lucentis will be a standard treatment option but cautioned that the drug is only managing - not curing - a chronic disease. In its current form, Lucentis is not a permanent fix, as patients must receive multiple, continuous treatments in order to sustain the progress made in restoring their vision.
In Rhodus' case, she needed nine treatments in the first year and six during the second year, which required her to travel frequently to Lexington from her home in Richmond.
There are numerous other research studies underway with other drugs for treating diabetic macular edema, as well as experimentation with self-administered treatments such as eye drops. Stone said he's confident that there will soon be a more durable treatment available for patients.
"We're not there yet, but it's coming," he said.
Stone said he hopes the FDA will move quickly on approving Lucentis, as he feels the clinical study has been sound and produced positive results. In the meantime, he will continue to administer the drug and track his study patients for years to come.
"We have a special relationship, a partnership with our diabetic patients," said Stone.
Rhodus agreed and talks fondly about her experiences with Stone.
"I feel like he's part of my family," she said.
With Kentucky's high national rank for the number of diagnosed diabetics, an effective treatment could improve the lives of many Kentuckians. However, it is no substitute for prevention. Stone said many Kentuckians may be putting themselves at risk of diabetes with unhealthy lifestyle choices.
"I have a number of patients who are business people who don't eat well, don't sleep well and don't exercise regularly," he said.
That lifestyle is responsible for a third of Kentuckians being obese. (See boxed statistics.) Stone said the most important things people can do for their health are to exercise, eat less processed food and stop smoking.
"Smoking is toxic to the blood vessels in the eyes," Stone said. "The impact on the lungs is well known, but most people don't know about the effects of smoking on our eyes."
Rhodus offeed her own advice to stave off diabetes and the medical complications she has experienced firsthand from the disease.
"Don't sit around," Rhodus said. "Get up and move."
For more information on study results and eye diseases related to diabetes, contact: Betsy Herrington, director of marketing & public relations, Retina Associates of Kentucky, (859) 263-3900 x111.