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As-needed dosing of anti-VEGFs requires diligence, speaker says
FORT LAUDERDALE, Fla. — As-needed dosing of ranibizumab and bevacizumab resulted in fewer total injections than did monthly dosing, but patients must be observed more carefully, according to a speaker here.
"We produced a very good PRN result, but it was achieved, I would argue ... by the diligent follow-up that we gave and the number of injections that we gave over that period of time," Daniel F. Martin, MD, said at the Association for Research in Vision and Ophthalmology meeting.
The Comparison of Age-Related Macular Degeneration Treatment Trials (CATT) included 1,185 patients receiving either monthly or as-needed injections of Avastin (bevacizumab, Genentech) or Lucentis (ranibizumab, Genentech) for 1 year.
Results of the landmark clinical trial were released last week by the National Eye Institute and published online in the New England Journal of Medicine.
Both bevacizumab and ranibizumab were found to produce nearly identical visual acuity outcomes.
Although as-needed dosing of either drug required four to five fewer injections than monthly dosing, Dr. Martin said that caution is needed in deciding when to conclude treatment.
"If [patients] leave it up to me, I do not think there is any difference between Avastin and Lucentis. I have seen nothing so far regarding adverse events that would concern me greatly, and I would probably start with Avastin," he said.
Dr. Martin and colleagues will observe the patients for 1 more year, and the results should be released in 2012, he said.
- Disclosure: Dr. Martin has no relevant financial interests to disclose.
The CATT is a seminal study that continues the proud tradition of ophthalmology as a leader in the design and execution of clinical trials. It provides the first level 1 evidence on the efficacy and safety of bevacizumab in comparison to ranibizumab for the treatment of neovascular AMD. The study investigators conclude that monthly injections of either drug provide equivalent visual benefit at 1 year.
Also, the study demonstrates that as-needed treatment with ranibizumab, as delivered in the study, is as effective as monthly treatment. However, as-needed treatment with bevacizumab may not be as effective as monthly treatment with either drug.
The safety data are for the most part reassuring, but the increased rate of serious adverse events with bevacizumab requires further study in larger populations.
It is important to recognize that the beneficial effects of treatment with either drug are dependent on the monthly treatment of active neovascularization as evidenced by OCT, hemorrhage, decreased visual acuity or fluorescein angiography. In the absence of active neovascularization, as-needed treatment with ranibizumab is equivalent to monthly treatment. Application of the CATT results to clinical practice requires monthly examination and OCT imaging. The CATT results should not be extrapolated to other follow-up intervals.
– George A. Williams, MD
OSN
Retina/Vitreous Board Member
Disclosure: Dr. Williams was an investigator
for the CATT.