Tampa, FL (April 25, 2006) -- Repeated injections of the investigational drug ranibizumab were safe and improved vision in patients with wet age-related macular degeneration (AMD) – a potentially blinding eye disease, reports a national study published online this month in the journal Ophthalmology.

In the wet form of macular degeneration, central vision loss is caused by abnormal blood vessel growth and leakage within the inner back lining of the eye where the retina processes images. Current laser treatment options for wet macular degeneration may prevent further vision loss but do not restore lost vision.

"This is the first treatment to show an improvement of vision in patients with wet age-related macular degeneration," said ophthalmologist Peter Reed Pavan, MD, principal investigator at the University of South Florida study site.  "Earlier treatments such as Verteporfin photodynamic therapy and Macugen injections into the eye slowed but did not reverse the loss of vision."

Ranibizumab is a therapeutic antibody fragment designed to bind and inhibit the uncontrolled growth of new blood vessels – an important factor in the development of wet AMD. 

The Phase I/II controlled open-label study involved 62 patients in eight centers across the country, including the USF Eye Institute. Dr. Pavan, professor and chair of Ophthalmology at USF Health, was among the study authors for the Ophthalmology journal article

Patients with AMD, age 50 or older, were randomized into three groups for the seven-month study. One group received monthly injections of 0.3 mg. ranibizumab, the second group received monthly injections of 0.5 mg. ranibizumab and the third group received usual care.

Ranibizumab was generally well tolerated. The most common side effects were mild to moderate and included painless reversible inflammation, minor hemorrhage at the injection site and increased intraocular pressure.

The study found that both groups of patients treated with ranibizumab gained visual acuity as demonstrated by an increase in the average number of letters they could read on the eye chart. Patients receiving usual care lost visual acuity, showing a decrease in the average number of letters read.

The patients treated with ranibizumab also had reduced blood vessel leakage compared to the patients receiving usual care.

The study was supported by Genentech, Inc. Dr. Pavan has served as a consultant to Genentech for Lucentis™ (ranibizumab).

- USF Health -

USF Health is the University of South Florida's enterprise of researchers, teachers and clinicians dedicated to improving the full continuum of health. Its core is the colleges of Public Health, Nursing and Medicine, including a School of Physical Therapy, as well as the healthcare delivered by its 450 physicians and more than 100 nurse practitioners. In partnership with its affiliated hospitals, USF Health's research funding last year was $134 million -- more than half of which came from federal sources. Last year, USF health clinicians cared for more than 31,000 patients and oversaw 396,000 outpatient visits.