|Comparison of AMD Treatments Trials (CATT): Lucentis — Avastin Trial
The National Eye Institute (NEI) of the National Institutes of
Health (NIH) announces the start of a multicenter clinical trial
to compare the relative safety and effectiveness of two drugs currently
used to treat advanced age-related macular degeneration (AMD).
The two drugs are Lucentis (ranibizumab) and Avastin (bevacizumab).
AMD is a disease that damages the macula. The macula is the area
of the retina responsible for central vision. AMD is a leading
cause of blindness among older Americans. Nearly two million Americans
are visually impaired by AMD, while more than seven million are
at increased risk of vision loss from the disease.
"Visual impairment from AMD can lead to loss of independence
and a reduced quality of life," said Paul A. Sieving, M.D.,
Ph.D., director of NEI. "This clinical trial will evaluate
whether the treatment burden for patients can be reduced without
Lucentis was approved by the U.S. Food and Drug Administration
(FDA) in June of 2006 for the treatment of advanced, or wet, AMD.
The approval was based on evidence from clinical trials showing
that Lucentis slows the rate of progression of vision loss from
wet AMD. In addition to a low rate of developing vision loss, approximately
one-third of patients treated in these trials had some improvement
in vision, as measured on an eye chart, at 12 months.
Avastin is a drug closely related to Lucentis. It was approved
by the FDA in 2004 as an intravenous treatment for patients with
advanced colorectal cancer and therefore has been available for
what is called off-label use for other health conditions. It
has been widely used off-label to treat wet AMD. Avastin is thought
to remain in the eye longer than Lucentis and therefore possibly
allow for less frequent injections.
Wet AMD occurs when abnormal blood vessels behind the retina start
to grow under the macula. These new blood vessels leak blood and
fluid, damaging the macula and causing a rapid loss of vision.
The growth of new blood vessels is called angiogenesis or neovascularization.
NIH-supported research has helped establish that a protein called
vascular endothelial growth factor (VEGF) is an important element
in angiogenesis. This research provided a stimulus for the development
of a number of anti-angiogenic or anti-VEGF drugs, including Lucentis
The Lucentis — Avastin trial will determine the relative safety
and effectiveness of treating wet AMD in 1,200 patients who will
be treated with either:
of Lucentis on a fixed schedule of once every four weeks
for one year, with the patient being assigned randomly in the second
year to either an injection of Lucentis every four weeks
or on a variable schedule depending on the patient's response
of Avastin on a fixed schedule of once every four weeks for
one year, with the patient being assigned randomly in the second
year to either an injection of Avastin every four weeks or
on a variable schedule depending on the patient's response
of Lucentis on a variable schedule;
of Avastin on a variable schedule.
The primary outcome measure will be change in visual acuity.
Secondary outcome measures will include number of treatments, anatomical
changes in the retina, adverse events, and cost.
This clinical trial will be conducted at 47 clinical centers across
the country. It is hoped the results of this study will improve
the treatment of wet AMD. Reducing the frequency of treatments
without compromising effectiveness would reduce the treatment burden
for patients and produce a potential cost savings.
For a list of clinical centers, eligibility recruitments, and
other information, go to: http://www.nei.nih.gov/CATT.
Lucentis and Avastin are products of Genentech, Inc.
The National Eye Institute (NEI) is part of the National
Institutes of Health (NIH) and is the federal government's lead
agency for vision research that leads to sight-saving treatments
and plays a key role in reducing visual impairment and blindness.
For more information, visit the NEI Website at http://www.nei.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.