Lucentis Effective for Proliferative Diabetic Retinopathy
November 16, 2015 - 12:00 PM
WASHINGTON, D.C. - A clinical trial funded by the National Institutes of Health has
found that the drug ranibizumab (Lucentis) is highly effective in
treating proliferative diabetic retinopathy. The trial, conducted by the
Diabetic Retinopathy Clinical Research Network (DRCR.net) compared
Lucentis with a type of laser therapy called panretinal or scatter
photocoagulation, which has remained the gold standard for proliferative
diabetic retinopathy since the mid-1970s. The findings demonstrate the
first major therapy advance in nearly 40 years.
“These latest results from the DRCR Network provide crucial evidence
for a safe and effective alternative to laser therapy against
proliferative diabetic retinopathy,” said Paul A. Sieving, M.D., Ph.D.,
director of NIH’s National Eye Institute (NEI), which funded the trial.
The results were published online today in the Journal of the American
Treating abnormal retinal blood vessels with laser therapy became the
standard treatment for proliferative diabetic retinopathy after the NEI
announced results of the Diabetic Retinopathy Study in 1976. Although
laser therapy effectively preserves central vision, it can damage night
and side vision; so, researchers have sought therapies that work as well
or better than laser but without such side effects.
A complication of diabetes, diabetic retinopathy can damage blood
vessels in the light-sensitive retina in the back of the eye. As the
disease worsens, blood vessels may swell, become distorted and lose
their ability to function properly. Diabetic retinopathy becomes
proliferative when lack of blood flow in the retina increases production
of a substance called vascular endothelial growth factor, which can
stimulate the growth of new, abnormal blood vessels. These new vessels
are prone to bleeding into the center of the eye, often requiring a
surgical procedure called a vitrectomy to clear the blood. The abnormal
blood vessels can also cause scarring and retinal detachment. Lucentis
is among several drugs that block the effects of vascular endothelial
About 7.7 million U.S. residents have diabetic retinopathy, a leading
cause of blindness among working-age Americans. Among these, about 1.5
percent have PDR.
The DRCR.net enrolled 305 participants (394 eyes) with proliferative
diabetic retinopathy in one or both eyes at 55 clinical sites across the
country. Eyes were assigned randomly to treatment with Lucentis or
laser. For participants who enrolled both eyes in the study, one eye was
assigned to the laser group and the other was assigned to the Lucentis
group. About half of the eyes assigned to the laser group required more
than one round of laser treatment. In the other group, Lucentis (0.5
mg/0.05 ml) was given via injections into the eye once per month for
three consecutive months, and then as needed until the disease resolved
Because Lucentis is commonly used to treat diabetic macular edema—the
build-up of fluid in the central area of the retina—the study permitted
the use of Lucentis for diabetic macular edema in the laser group, if
necessary. Slightly more than half (53 percent) of eyes in the laser
group received Lucentis injections to treat diabetic macular edema.
About 6 percent of eyes in the Lucentis group received laser therapy,
mostly to treat retinal detachment or bleeding.
At two years, vision in the Lucentis group improved by about half a
line on an eye chart compared with virtually no change in the laser
group. There was little change in side vision with injection (average
worsening of 23 decibels) but a substantial loss of side vision with
laser (average worsening of 422 decibels). The vitrectomy rate was
lower in the Lucentis group (8 of 191 eyes) than in the laser group (30
of 203 eyes).
Rates of serious systemic adverse events, including cardiac arrest
and stroke, were similar between the two groups. One patient in the
Lucentis group developed endophthalmitis, an infection in the eye. Other
side effects were low, with little difference between treatment groups.
“Lucentis should be considered a viable treatment option for people
with proliferative diabetic retinopathy, especially for individuals
needing anti-vascular endothelial growth factor for diabetic macular
edema,” said Jeffrey G. Gross, M.D., of the Carolina Retina Center in
Columbia, South Carolina, who chaired the study. Dr. Gross presented
results November 13, 2015, at the annual meeting of the American Academy
of Ophthalmology in Las Vegas.
In addition to treating proliferative diabetic retinopathy, the
report suggests Lucentis may even help prevent diabetic macular edema
from occurring. Among people without diabetic macular edema at the start
of the study, only 9 percent of Lucentis-treated eyes developed
diabetic macular edema during the study, compared with 28 percent in the
laser group. The DRCR.net will continue to follow patients in this
study for a total of five years.
The DRCR.net is dedicated to facilitating multicenter clinical
research of diabetic eye disease. The network formed in 2002 and
comprises more than 350 physicians practicing at more than 140 clinical
sites across the country. For more information, visit the DRCR.net
website at http://drcrnet.jaeb.org/ (link is external).
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