News Releases

April 29, 2011

NIH Study Finds Avastin and Lucentis Are Equally Effective In Treating Age-Related Macular Degeneration

Media contact: Joy Bell, 404-778-3711, jbell@emory.edu

(ATLANTA) Emory Eye Center and other study centers have been a part of a two-year national clinical trial evaluating two drugs for age-related macular degeneration (AMD). Results from the first year of the trial among 43 eye institutions show that Avastin—a drug approved to treat some cancers and that is commonly used off-label to treat age-related macular degeneration (AMD)—is as effective as the Food and Drug Administration-approved drug Lucentis for the treatment of AMD.

The report, from the Comparison of AMD Treatments Trials (CATT), was published online in the New England Journal of Medicine on Thursday, April 29, 2011. CATT is funded by the National Eye Institute (NEI), a part of the National Institutes of Health.

"Over 250,000 patients are treated each year for AMD, and a substantial number of them receive Avastin. Given the lack of efficacy data regarding Avastin for AMD treatment, the NEI had an obligation to patients and clinicians to conduct this study," said Paul A. Sieving, MD, PhD, director of the NEI.

Retina specialist Baker Hubbard, MD, was the principal investigator of the trial at the Emory Eye Center. “We all owe a tremendous debt of gratitude to the patients who participated in this research and adhered to the rigorous protocol of monthly evaluations and injections over a period of now more than a year," he says. "Through their dedication we have learned a tremendous amount about the two most important new drugs in the last decade in ophthalmology.”

“I’m very relieved that the patients that we’ve been treating for years using off-label bevacizumab have non-inferior outcomes to those treated with ranibizumab at the one-year time point,” says Emory Eye Center director Timothy W. Olsen, MD. “The potential cost savings to the healthcare system is extraordinary. The data is very interesting and following the trends out further for the second year of the study will be important.”

Background
AMD is the leading cause of vision loss and blindness in older Americans. In its advanced stages, the wet form of AMD spurs the growth of abnormal blood vessels, which leak fluid and blood into the macula and obscure vision. The macula is the central portion of the retina that allows us to look straight ahead and to perceive fine visual detail. Accumulation of fluid and blood damages the macula, causing loss of central vision. AMD can severely impede mobility and independence. Many patients are unable to drive, read, recognize faces or perform tasks that require hand-eye coordination.

Genentech, the maker of both drugs, originally developed Avastin to prevent blood vessel growth that enables cancerous tumors to develop and spread. In 2004, the FDA approved Avastin for the systemic treatment of metastatic colon cancer. Genentech later developed Lucentis, derived from a protein similar to Avastin, specifically for injection in the eye to block blood vessel growth in AMD.

In 2005, two Genentech-sponsored clinical trials established Lucentis as highly effective for the treatment of wet AMD. During the year between the announcement of the trial results and the release of Lucentis, ophthalmologists began injecting AMD patients with low doses of Avastin, due to its similarity to Lucentis and its availability. The FDA has not licensed Avastin for the treatment of AMD.

Numerous physicians noted a beneficial treatment effect and Avastin's use grew rapidly despite the lack of data on safety, efficacy and dosing from randomized clinical trials to support its use. Ophthalmologists used Avastin primarily as needed, or pro re nata (PRN), when there was evidence of active disease.

The FDA approved Lucentis in 2006. However, most clinicians adopted PRN dosing for Lucentis, which was a departure from FDA-approved labeling and the monthly dosing schedule evaluated in the Genentech-sponsored clinical trials. It was not known if PRN dosing would produce the same long-term vision benefits that were achieved with monthly administration.

The process
NEI launched CATT in 2008 to compare Lucentis and Avastin for treatment of wet AMD. The study has now reported results for 1,185 patients treated at 43 clinical centers in the United States. Patients were randomly assigned and treated with one of four regimens for a year. They received Lucentis monthly or PRN, or Avastin monthly or PRN. Enrollment criteria required that study participants had active disease.

Patients in the monthly dosing groups received an initial treatment and then had an injection every 28 days. Patients in the PRN groups received an initial treatment and were then examined every 28 days to determine medical need for additional treatment. PRN groups received subsequent treatment when there were signs of disease activity, such as fluid in the retina. Ophthalmologists involved in patient care did not know which study drug a patient was getting, to make sure that the data was not affected by how anyone felt about the treatment.

Outcomes
Change in visual acuity served as the primary outcome measure for CATT. Thus far, visual acuity improvement was virtually identical (within one letter difference on an eye chart) for either drug when given monthly. In addition, no difference was found in the percentage of patients who had an important gain or loss in visual function. Also, when each drug was given on a PRN schedule, there also was no difference (within one letter) between drugs. PRN dosing required four to five fewer injections per year than monthly treatment. Visual gains were about two letters less with PRN than with monthly treatment but overall visual results were still excellent.

Adverse events indicate development or worsening of a medical condition. They may or may not be causally associated with the clinical trial treatment, but they are always monitored and reported in any clinical trial. The median age of patients in CATT was over 80 years, and a high rate of hospitalizations might be anticipated as a result of chronic or acute medical conditions more common to older populations.

Serious adverse events (primarily hospitalizations) occurred at a 24 percent rate for patients receiving Avastin and a 19 percent rate for patients receiving Lucentis. These events were distributed across many different conditions, most of which were not associated with Avastin in cancer clinical trials where the drug was administered at 500 times the dose used for AMD. The number of deaths, heart attacks, and strokes were low and similar for both drugs during the study. CATT was not capable of determining whether there is an association between a particular adverse event and treatment. Differences in serious adverse event rates require further study.

Investigators in the CATT study will continue to follow patients through a second year of treatment. The additional data will provide information on longer-term effects of the drugs on vision and safety.

The FDA has not evaluated data from the CATT trial.

Find more information about this clinical trial (NCT00593450) at http://www.clinicaltrials.gov.

The National Eye Institute, part of the National Institutes of Health, leads the federal government's research on the visual system and eye diseases. NEI supports basic and clinical science programs that result in the development of sight-saving treatments. For more information, visit http://www.nei.nih.gov.

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