Posted: Jun 29, 2011 10:03 PM
June 29, 2011 (San Diego) -- Lucentis, a drug used to treat people with vision problems from age-related macular degeneration, may help to restore vision among people with eye complications caused by diabetes, two studies suggest.
The studies involved 759 patients with diabetic macular edema, a swelling in an area of the retina that sometimes leads to vision loss.
Two to three times as many patients given Lucentis could read an additional three lines on the eye chart, compared with patients given a placebo, says David S. Boyer, MD, of Retina-Vitreous Associates Medical Group in Los Angeles.
Vision improved from 20/80 to 20/40 (required to drive legally) in about two-thirds of people on Lucentis, he says. Most of the patients started with 20/80 vision, meaning their eyesight at 20 feet was the same as that of an average person at 80 feet.
Boyer presented the results here at the annual meeting of the American Diabetes Association.
Macular edema is one of the most serious forms of diabetic retinopathy and a leading cause of blindness in people with diabetes, according to David M. Kendall, MD, chief scientific and medical officer for the American Diabetes Association. About 10% of diabetic patients develop diabetic macular edema (DME).
For several decades, laser has been the standard treatment for DME, in which swelling builds up near the center of the retina.
"The question has been, can a treatment be sight-preserving in patients with macular edema without resorting to laser therapy," he tells WebMD. "The answer is yes, Lucentis appears to be effective and in some cases, even sight-restoring, which laser treatment is not," says Kendall, who was not involved with the studies.
Lucentis was approved in 2006 for age-related macular degeneration (AMD). AMD, the leading cause of blindness in the U.S., is the result of abnormal growth and leakage of blood vessels in the retina.
Lucentis prevents abnormal blood vessel growth by blocking a protein called VEGF.
One of the new studies, dubbed RISE, involved 377 patients. About 45% of those given a lower dose of Lucentis and 39% of those on a higher dose recovered at least 15 letters (three lines) on an eye chart vs. 18% given sham injections.
Nearly two-thirds of those on the higher Lucentis dose recovered enough eyesight to be able to legally drive, compared with 38% of those getting a placebo.
In the other, 382-patient study, called RIDE, 34% on a low dose of Lucentis and 46% of those on a higher dose were able to read an additional 15 or more letters on the eye chart, compared with 12% of patients getting placebo.
About 54% on the low Lucentis dose and 62% on the high dose recovered enough vision to be able to drive, compared with 35% receiving a sham treatment.
Nearly three in four patients on placebo required rescue laser treatments to stabilize vision vs. only 29% to 39% of Lucentis-treated patients.
Patients in both studies were given either sham or Lucentis shots for 24 months.
The Lucentis injections were generally safe, with overall side effects similar to those of sham injections, Boyer says.
However, cardiovascular problems, which included heart attacks, strokes, and deaths due to vascular conditions, affected 6% to 9% of patients given the higher dose of Lucentis compared with about 5% on sham.
High blood pressure was also more common with high-dose Lucentis: 2% to 3% vs. 0% to 1% with sham.
The studies were funded by Genentech. The company plans to submit the studies to the FDA later this year to seek approval for use of Lucentis in DME.
These findings were presented at a medical conference. They should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.