Macular Degeneration

ARVO: Two-Year Safety Equal in AMD Drug Trial

Overview CATT Study


ARVO: Two-Year Safety Equal in AMD Drug Trial

By John Gever, Senior Editor, MedPage Today

Published: May 02, 2011

FORT LAUDERDALE -- Preliminary two-year safety data from the landmark CATT trial of biologic drugs for macular degeneration partially reversed conclusions from the one-year results reported last week, study leaders said in an oral presentation Sunday.

Major adverse events during the trial's second year appeared to be about equal, in contrast with the one-year results which suggested that ranibizumab (Lucentis) might be somewhat safer than off-label bevacizumab (Avastin) for patients with wet age-related macular degeneration (AMD).

The one-year results were reported online in the New England Journal of Medicine last week. Publication had been expected to coincide with an oral presentation Sunday at the Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale, Fla., but was rushed out after top-line results were leaked to the New York Times.

Nevertheless, when study co-leaders Daniel Martin, MD, of the Cleveland Clinic, and Maureen Maguire, PhD, of the University of Pennsylvania, took the podium at ARVO on Sunday, they surprised attendees with some data not included in the NEJM paper -- a glimpse of safety results in patients completing the study's second year of treatment.

They showed that rates of death, stroke, and all arteriothrombotic events were equal between the two drugs during the trial's second year:

These data did not distinguish between the two treatment regimens that were tested in the four-arm trial, which was sponsored by the National Eye Institute. Patients received one of the two drugs by intravitreal injection either on a fixed monthly schedule or "as needed," based on whether fluid buildup was detected in retinal imaging conducted monthly.

According to the data reported in NEJM, serious systemic adverse events in aggregate during the first year were significantly more common with bevacizumab (HR 1.29, 95% CI 1.01 to 1.66).

Efficacy data from the second year of the CATT (Comparison of AMD Treatment Trials) study were not reported at the ARVO session. Those data are expected to be released at a later meeting.

Top-line efficacy results from the one-year data indicated that the two drugs were nearly equal to each other and that as-needed dosing was effective but slightly less so than the fixed monthly schedule.

During their presentation, Martin and Maguire highlighted five issues still to be answered in the full two-year data. Those include whether:

Lynne Peterson in Ft. Lauderdale contributed to this report.