New Drug Treatment May Help Elderly with Wet AMD
Keep Driving Longer
Small, limited Hopkins study used ranibizumab but did
not directly assess driving safety or skills
Oct. 2, 2012 - Results of a new study indicate that
monthly injections of ranibizumab (Lucentis) can improve eye chart test
results required for a driver's license, build driver confidence and
keep the elderly with the wet form of age-related macular degeneration
(AMD) driving longer.
The advanced neovascular, or "wet," form of AMD,
left untreated, is the most common cause of vision loss among the
elderly and a leading reason for their loss of driving privileges,
according to the study from Johns Hopkins Medicine published in the
online version of the journal Ophthalmology.
The wet form of AMD is marked by the abnormal
scarring and leaking of new blood vessels in the macula, or center of
the retina, the light-sensitive layer of the eye used for driving,
reading or recognizing faces.
Treatment with ranibizumab, a drug made partly from
a human monoclonal antibody fragment, is done by injecting it monthly
(or as needed with frequent evaluations) into the middle of the eye with
a tiny needle about the diameter of a hair. The medicine eliminates or
slows new scar and leaking blood vessel formation.
"Driving is an important measure of independence
and quality of life for many people in the United States. Participants
with wet AMD in our study perceived that they were not driving because
of their diminished eyesight," said senior author, Neil M. Bressler,
M.D., the James P. Gills Professor of Ophthalmology and chief of the
Retina Division at the Wilmer Eye Institute at Johns Hopkins Medicine.
"Our study, believed to be the first of its kind to
look at whether outcomes relevant to driving improve with treatment,
suggests that monthly injections of ranibizumab may be an extremely
helpful option in allowing the elderly to continue driving."
During the phase III, multicentered, randomized
two-year clinical trial, researchers used a 25-item National Eye
Institute Visual Function Questionnaire to measure study participants'
driving ability, perception and self-reported driving status in two
Investigators also conducted monthly assessments,
over a two-year period, of the best corrected vision in each eye of
1,126 patients enrolled in these studies that evaluated treatments for
AMD. One study compared results for those receiving ranibizumab versus
sham (fake) injections; the second compared results of ranibizumab
injections versus photodynamic (laser) therapy (PDT) that can seal
abnormally leaking blood vessels.
Based on the results of two previous reports from
these studies, ranibizumab was better than sham and PDT treatments with
respect to avoiding loss of vision when treating patients with an eye
affected by wet AMD. This new analysis of those trials by Bressler and
colleagues looked beyond the results of these treatments on reading an
eye chart to clinically relevant outcomes regarding the impact of this
treatment on driving in three ways:
● treatment versus no treatment in those who
said they were driving or not driving at the beginning and end of the
● treatment versus no treatment in participants
who had vision at the beginning and end of the study that would qualify
them for an unrestricted driver's license in at least 45 of the U.S.
● a standardized questionnaire assessing the
patients' own perception about the level of difficulty driving in
difficult conditions such as rain or fog or at night.
The 45 states all require correctable vision of at
least 20/40 in one eye to qualify for an unrestricted driver's license.
"What the study showed was that 85 percent of
participants in the ranibizumab versus sham study and 88 percent in the
ranibizumab versus PDT study read the eye chart better also achieved the
level of vision required for an unrestricted license and in turn had
greater confidence in driving," noted Bressler.
The researchers cautioned that more research is
needed to determine whether driving skills or driving safety are
actually maintained or improved, and whether they match up with patient
perceptions of their abilities reported on the questionnaire.
About Ranibizumab Injection (ra'' ni biz' oo mab)
Brand name: Lucentis
Why is this medication prescribed?
Ranibizumab is used to treat wet age-related
macular degeneration (AMD; an ongoing disease of the eye that causes
loss of the ability to see straight ahead and may make it more difficult
to read, drive, or perform other daily activities). Ranibizumab is in a
class of medications called vascular endothelial growth factor A (VEGF-A)
antagonists. It works by stopping abnormal blood vessel growth and
leakage in the eye(s) that may cause vision loss in people with wet AMD.
How should this medicine be used?
Ranibizumab comes as a solution (liquid) to be
injected into the eye by a doctor. It is usually given in a doctor's
office every month. Your doctor may give you injections on a different
schedule if that is best for you.
Before you receive a ranibizumab injection, your
doctor will clean your eye to prevent infection and numb your eye to
reduce discomfort during the injection. You may feel pressure in your
eye when the medication is injected. After your injection, your doctor
will need to examine your eyes before you leave the office.
Ranibizumab controls wet AMD, but does not cure it.
Your doctor will watch you carefully to see how well ranibizumab works
for you. Talk to your doctor about how long you should continue
treatment with ranibizumab.
"Our study has limitations because these two
studies were not designed to directly assess the impact of ranibizumab
on driving, and because there was just a small number of patients in the
groups that were analyzed relative to the hundreds of thousands of
patients affected by the wet form of AMD each year around the world,"
"One of our next steps is to look at these same
outcomes when treatment is given for diabetic macular edema, swelling at
the center of the retina as a result of diabetes, the most common cause
of vision impairment in working-age adults in the U.S. and abroad."
Other researchers in the study included Genentech
consultants Tom S. Chang, M.D., from the Retina Institute of California;
Rohit Varma, M.D., M.P.H., Doheny Eye Center; Ivan J. Suρer, M.D.,
Retina Associates of Florida; Paul Lee, M.D., Duke Eye Center, Duke
University School of Medicine, Durham, N.C.; Chantal M. Dolan, Ph.D.,
Genentech, Inc., San Francisco; James Ward, Ph.D., Genentech, Inc., San
Francisco; Tsontcho Ianchulev, M.D., Ph.D., affiliated with the
University of California, San Francisco and Jennifer T. Fine, Sc.D.,
Transcend Medical, Menlo Park, Calif.
Notes on Studys Support
Neil M. Bressler, M.D., receives funding support
from Allergan, Bausch & Lomb, Carl Zeiss Meditec, Genentech (which makes
ranibizumab and markets it in the United States under the name Lucentis),
Notal Vision, Inc., Novartis (which markets ranibizumab outside of the
United States), Othera, QLT, Regeneron (which makes aflibercept and
markets it in the United States under the name Eylea and competes
directly with ranibizumab), and Steba Pharmaceuticals for sponsored
projects by the Department of Ophthalmology. Bressler receives salary
support for these sponsored projects; the terms of these projects are
negotiated and administered by JHU's Office of Research Administration.
Under JHU's policy, support for the costs of research, administered by
the institution, does not constitute a conflict of interest.
More Links to Archived Reports on
Senior Citizens and Driving