April 28, 2010 -- Federal researchers say a new treatment can reverse vision
loss in many patients with diabetic macular edema, a leading cause of blindness
in people with diabetes.
In a news conference yesterday, researchers announced findings from a
government study comparing treatments for swelling of the retina caused by
leaking blood vessels in the eye.
Nearly 50% of patients given eye injections of the drug Lucentis along with
laser treatments showed improvement in vision after a year of treatment,
compared to just over a fourth of patients treated with laser alone.
For several decades, laser has been the standard treatment for diabetic
macular edema, or DME, in which fluid builds up near the center of the
“For the first time in 25 years we have definitive proof that a new
treatment can lead to better results for the eye health of people with
diabetes,” said Neil M. Bressler, MD, who oversaw the study as chairman of the
Diabetic Retinopathy Clinical Research Network.
Lucentis is a genetically engineered drug derived from the cancer drug
Avastin, which was the first targeted biologic treatment approved by the
The newer biologic was approved in June 2006 for the treatment of
age-related macular degeneration, which is the leading cause of blindness in
Bressler said the clear superiority of Lucentis with laser over laser alone
in patients with diabetic macular edema should have an immediate impact on
clinical practice, even though the biologic treatment is not approved for this
“We expect the results of this study to have a major impact on how
ophthalmologists treat macular edema in people with diabetes,” he says.
The study included 691 diabetic patients with macular edema in one or both
The patients received either standard laser treatment alone, Lucentis plus
laser treatments in different dosing schedules, or the injectable steroid drug
Trivaris with standard laser therapy.
Lucentis injections were limited to once a month, but most patients ended up
having no more than eight or nine injections over the course of a year.
Few Complications, Better Outcomes
After one year, nearly 50% of the Lucentis-treated patients could read at
least two additional lines on an eye chart or letters that were one-third
smaller than could be recognized before treatment.
Vision loss, defined as loss of two or more lines on an eye chart, was seen
in less than 5% of the patients treated with the biologic drug.
Patients treated with injections of the corticosteroid Trivaris and laser
showed no greater improvement in vision than patients treated with laser
These patients did have greater reduction in retina thickness, but they also
experienced more treatment-related complications than other study
About 30% developed potentially serious eye pressure requiring medication
and 60% developed cataracts.
Few eye-related complications were reported in the Lucentis-treated
patients, and these patients appeared to have no greater risk of heart attack
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