Bevacizumab Injections Superior to Pegaptanib, Photodynamic Therapy for Neovascular Age-Related Macular Degeneration: Presented at RC2009
By Cameron Johnston
NEW YORK -- October 5, 2009 -- A small trial has shown that intravitreal injections of bevacizumab given every 6 weeks followed by as-needed re-treatments is superior to either injections of pegaptanib, photodynamic therapy (PDT), or sham treatments in the management of neovascular age-related macular degeneration (AMD).
Adnan Tufail MD, Moorfields Eye Hospital, London, United Kingdom, presented the results in an oral presentation here on October 1 at the Retina Congress (RC) 2009.
The study was started before ranibizumab had been approved for the treatment of macular degeneration, and therefore, the comparator arms were made up of what was the standard treatment at the time. Though the findings may be muted by the approval of ranibizumab in the United Kingdom, this was still the first prospective, double-blind, randomised controlled trial to compare bevacizumab with another treatment.
In the study,
65 patients were randomised to receive bevacizumab 1.25 mg every 6 weeks for 3 doses, followed by as-needed dosing,
and
66 patients received either PDT every 3 months or pegaptanib injections every 6 weeks. A third arm of patients received a sham injection every 6 weeks for 3 doses.
Re-treatments were offered if the patient experienced a loss of >=5 ETDRS letters, or an increase of >=100 microns in central retinal thickness.
Re-treatments were also given when new classic lesions were observed, when there were signs of new retinal haemorrhage, or when new subretinal fluid was seen.
After 54 weeks of follow-up, one-third of patients (21/65) treated with bevacizumab experienced an improvement in best corrected visual acuity (VA) of at least 15 letters
compared with
3% (2 /66) who underwent standard care. The mean gain in VA was 7.0 letters compared with a loss of 9.4 letters from baseline for the 2 groups, respectively.
In addition, patients receiving bevacizumab were much less likely to lose more than 15 letters (90.8%) compared with patients who received standard care (66.7%).
The treatment was particularly effective for patients with predominantly classic lesions (44% had an improvement of >15 letters).
Importantly, Dr. Tufail said, there was no marked drop-off in VA when the patients receiving bevacizumab switched from dosing every 6 weeks to as-needed dosing.
This is a phenomenon that has been seen in other studies where loading doses have been followed by an intermittent or staggered re-treatment protocol.
In general, Dr. Tufail added, the benefits seen at week 18 were carried out to week 54.
As for safety issues, there were 2 cases of myocardial infarction (1 fatal)
and
2 cases of uveitis, but no other ocular adverse events were seen in patients receiving bevacizumab.
There were limitations to this study. As Dr. Tufail noted, the study was started before ranibizumab was available in the United Kingdom, which means the standard of care used in the trial is now outdated.
Nonetheless, the treatment regimen with bevacizumab is still a valuable option, with positive VA outcomes, as well as few side effects, and it continues to play a role in the treatment of many patients, despite the increase in the use of ranibizumab.
The 2009 Retina Congress is a combined meeting of the American Society of Retina Specialists, the Macula Society, and the Retina Society.
[Presentation title: Bevacizumab for Neovascular Age-Related Macular Degeneration (ABC Trial): A Randomized, Double-Masked Study]
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