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Ranibizumab regimen favorable in nAMD.

In papers published in 2006, ranibizumab, an antivascular endothelial growth factor antibody, proved effective in the treatment of neo-vascular age-related macular degeneration in phase III trials. In those trials, the treatment was delivered by intravitreal injection on a fixed, monthly schedule for 2 years.

Attempts to lengthen the intervals between injections in subsequent trials produced less favorable visual outcomes.

But a new study suggests that extended regimens can be as effective as fixed regimens if they are introduced gradually and tailored to the individual patient.

In a retrospective study, Dr. Omesh P. Gupta and colleagues from the Wills Eye Institute at Thomas Jefferson University, Philadelphia, have demonstrated encouraging improvements in patients' visual acuity using an individualized treat-and-extend regimen.

Moreover, average annual medical costs tended to be substantially lower in patients on this regimen (Ophthalmology 2010 June 29 [doi:10.1016/j.ophtha.2010.02.032]).

The study involved 92 eyes in 92 patients with diagnoses of neo-vascular age-related macular degeneration (nAMD) who were treated between May 2006 and May 2008. Patients were naive to treatment and were managed with the regimen and at least 6 months of follow-up. The mean age was 80.6 years, and 66.3% of the patients were women.

In the treat-and-extend regimen, patients started out with monthly intravitreal injections of ranibizumab until they showed no signs of macular hemorrhage and no intraretinal or subretinal fluid on optical coherence tomography.

At that point, clinicians began to extend the treatment intervals by about 2 weeks at each visit if there were no signs of recurrent exudation. If such signs were present, or if the patient showed a decline in visual acuity, the treatment interval was shortened by 2 weeks.

In this way, the patients' mean longest period of extension grew to 80 days.

Patients received a mean of 8.4 injections over the first year of the study and 7.5 injections between years 1 and 2.

At baseline, the patients' mean Snellen visual acuity was 20/135. Their mean visual acuity improved significantly to 20/85 at 3 months, to 20/77 at 12 months, and to 20/83 at 24 months. At the 12-month follow-up period, 96% of the patients had lost fewer than three lines of Snellen visual acuity, and 32% improved by three or more lines of visual acuity.

The mean direct medical cost per patient on the treat-and-extend regimen was $16,114.52 during year 1 and $13,971.44 during year 2.

In contrast, the direct medical cost of fixed-interval treatments in one of the pivotal phase III studies was $28,314.16.

The investigators acknowledged the inherent limitations of their retrospective study, including reliance on nonprotocol vision measurements. But given the limitations of retrospective study design of unmasked participants and nonprotocol visions, the treat-and-extend regimen demonstrated "favorable visual out comes with fewer patient visits, fewer treatments, and lower associated direct medical costs," compared with the phase III pivotal trials.


Major Finding: Patients on the treat-and-extend regimen of renibizumab showed acuity improvements from 20/135 to 20/83 at the 2-year follow-up. Annual treatment costs averaged $16,114.52 with this regimen, compared with up to $28,314.16 using fixed-schedule injections.

Data Source: Retrospective analysis of data from 92 eyes in 92 patients followed for a mean of 1.5 years.

Disclosures: One of the investigates disclosed serving as a consultant and lecturer for Genentech Inc. Another disclosed serving as a Consultant for Genentech, Novartis, and Alcon Inc.

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Title Annotation:OPHTHALMOLOGY
Author:Finn, Robert
Publication:Internal Medicine News
Geographic Code:1USA
Date:Aug 1, 2010
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