ANTIBIOTIC EFFECTIVE AGAINST LEADING CAUSE OF BLINDNESS THROUGHOUT THE WORLD

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U.S. Department of Health and Human Services 
NATIONAL INSTITUTES OF HEALTH 
NIH News 
National Eye Institute (NEI)
http://www.nei.nih.gov/

EMBARGOED FOR RELEASE: Monday, March 13, 2006; 4:00 p.m. ET

CONTACT: National Eye Institute, 301-496-5248, neinews@xxxxxxxxxxx

Photos and other materials available in downloadable, camera-ready
format on the NEI Website at http://www.nei.nih.gov/trichiasis.

ANTIBIOTIC EFFECTIVE AGAINST LEADING CAUSE OF BLINDNESS THROUGHOUT THE
WORLD
A Single Dose of One Antibiotic for Treating Trichiasis is More
Effective than a Six-week Regimen of Another Antibiotic

A clinical trial funded by the National Eye Institute (NEI), part of the
National Institutes of Health (NIH), has concluded that a single dose of
azithromycin taken by mouth after surgery reduces by one-third the
recurrence of a vision-threatening eyelid condition called trichiasis.
This is in contrast to the usual six-week regimen of tetracycline
ointment applied directly to the eye. This study is published in the
March 2006 issue of "Archives of Ophthalmology".

"This study illustrates the importance of NIH clinical trials to find
treatments for diseases that affect people throughout the world," said
Elias A. Zerhouni, M.D., director of the NIH. "When we consider that an
estimated 11 million people worldwide develop trichiasis every year, we
see the impact that the findings of this study may have in preventing
future vision loss."

Trichiasis is a condition in which the eyelid turns inward and eyelashes
rub against the eye, resulting in corneal scarring and loss of vision.
It results from trachoma, an eye infection that is the leading
preventable cause of blindness in the world. It is spread through
contact with flies and other insects, clothing or household items that
harbor the bacterium, or infected people.

Trachoma occurs in poor, overcrowded communities that have little access
to clean water, waste treatment facilities, or health care. These
communities are located mainly in Africa, the Middle East, Asia,
Australia and some areas of Latin America.

The World Health Organization (WHO) previously endorsed a multi-faceted
strategy to control trachoma, including surgery for trichiasis and
application of tetracycline after surgery.

In this study, called Surgery for Trichiasis, Antibiotics to Prevent
Recurrence (STAR), eye infection with the bacterium that causes trachoma
was present in 19 percent of the adults with trichiasis in Wolayta Zone,
Ethiopia, the location of the clinical trial. More than 77 percent of
the patients were women, who have four times the rate of trichiasis than
men. Women often contract trachoma repeatedly by taking care of infected
children.

"This clinical trial was relatively inexpensive to conduct, and produced
results that may well save the vision of millions of people," said Paul
A. Sieving, M.D., Ph.D., director of vision research at NIH. "We look
forward to supporting future trials to treat blinding eye diseases
worldwide."

"The simple surgical repair of the eyelid to prevent blindness has been
plagued by high rates of recurrence of trichiasis -- up to 50 percent in
some areas," said study chairman Sheila K. West, Ph.D., Wilmer Eye
Institute, Johns Hopkins University. "In this study, by administering a
single dose of azithromycin after eyelid surgery, we were able to reduce
recurrence of trichiasis by 33 percent. This finding has major
implications for improving the outcome following surgery."

Continuing, Dr. West explained, "Some of the high rate of recurrence, no
doubt, is due to poor surgical technique. Surgeons should be well
trained and certified to ensure optimal outcomes. Future trials will
need to standardize the procedure when testing surgical therapies."

For this trial, the researchers from Wilmer Eye Institute partnered with
ORBIS International, a nonprofit organization that works to eliminate
blindness in developing countries. ORBIS trained Integrated Eye Care
Workers (IECWs) to perform the eyelid surgeries, and Wilmer Eye
Institute certified them, following WHO guidelines to ensure quality.
The surgeries performed by the IECWs were as successful as those
performed by ophthalmologists, and recurrence rates overall were low.

The results of this clinical trial, Dr. West believes, are transferable
to other settings because most countries with widespread trichiasis now
have access to a free azithromycin distribution program.

Thomas Quinn, M.D., an investigator with the National Institute of
Allergy and Infectious Diseases, another component of NIH, and Johns
Hopkins University, was a collaborator and co-author on the study.

Pfizer, Inc., through the International Trachoma Initiative that it
co-sponsors with the Edna McConnell Clark Foundation, provided the
azithromycin used in this trial.

For more information about eye health, the causes and treatment of
vision problems and much more, visit the National Eye Institute Web site
at www.nei.nih.gov.

The National Eye Institute 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. The NIH is an agency of the U.S.
Department of Health and Human Services.

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 http://www.nih.gov.

##
 
This NIH News Release is available online at:
http://www.nih.gov/news/pr/mar2006/nei-13.htm.

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