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Studies support several scenarios for treating wet AMD
CATT and IVAN studies show monthly ranibizumab, bevacizumab were non-inferior in terms of mean change in visual acuity. VIEW studies show aflibercept as non-inferior to ranibizumab in terms of efficacy.
CHICAGO — Clinical trials comparing three anti-VEGF agents offer retina specialists a wide range of treatment options for neovascular age-related macular degeneration, a speaker said here.
During Retina Subspecialty Day preceding the joint meeting of the American Academy of Ophthalmology and Asia-Pacific Academy of Ophthalmology, Peter K. Kaiser, MD, shared pearls on how to apply results of the CATT, IVAN, VIEW, MANTA and HARBOR studies in everyday clinical practice.
“You can interpret the results of those clinical studies any way you want, based on your particular baseline bias,” Kaiser, an OSN Retina/Vitreous Board Member, said. “Everyone sees the results of these studies how they want to see them.”
The studies compared various combinations and monotherapies of Avastin (bevacizumab, Genentech), Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron).
Blue laser autofluorescence (left) and color (right) images of neovascular age-related macular degeneration.
Image: Heidelberg Engineering
In a subsequent interview, fellow presenter Pravin U. Dugel, MD, summarized the intrinsic scientific value of the studies and noted possible safety concerns surrounding bevacizumab.
“The bottom line is that we have three excellent anti-VEGF drugs: Lucentis, Eylea and Avastin,” Dugel, an OSN Retina/Vitreous Board Member, said. “The first two are FDA approved for neovascular macular degeneration, and the third is not. However, there is more experience with the third than with the first two combined. Nonetheless, it is important to state that the level of scientific rigor applied to Lucentis and Eylea has not been applied to Avastin. There are safety trends that must be investigated. These important comparative studies are the first step of a rigorous scientific query.”
Ranibizumab and bevacizumab
One-year data from the CATT and IVAN studies showed that monthly ranibizumab and bevacizumab were non-inferior in terms of mean change in visual acuity. The MANTA study showed that as-needed ranibizumab and bevacizumab were non-inferior. In addition, aflibercept was clinically equivalent to ranibizumab in the VIEW studies.
“In that case, if you were a baseline bevacizumab user, you would look at these studies and say, ‘Using the transitive property, bevacizumab equals ranibizumab which equals aflibercept, and therefore, I should be using bevacizumab since they are all equal,’” Kaiser said.
In the CATT, as-needed bevacizumab performed poorly compared with the other treatment regimens, he said.
“So if you were a baseline Lucentis user, you would look at the data and say, ‘I do not want to treat monthly. I like to treat my patients as needed,’” Kaiser said. “In that case, I should continue to use ranibizumab as needed because in the CATT study, it was non- inferior to monthly treatments. And if you look at the number of injections in the as-needed groups, there were fewer injections with ranibizumab than with bevacizumab.”
Ranibizumab typically dried subretinal fluid more rapidly than bevacizumab in the trials, Kaiser said.
“So a baseline ranibizumab user would say, ‘I like a dry retina, and ranibizumab dries faster,’” he said. “In the first month, you already saw a difference between ranibizumab and bevacizumab in terms of drying of the retina. This persisted after 24 months, where the patients who received Lucentis monthly had the driest retinas, and that’s why I use Lucentis.”
The CATT was not powered to gauge differences in safety between ranibizumab and bevacizumab, Kaiser said.
Aflibercept and ranibizumab
If someone were an aflibercept user, he or she would argue that aflibercept emerged as the overall “winner” in the studies, Kaiser said. The efficacy of 8-week dosing of aflibercept was identical to that of monthly ranibizumab, he said. In addition, fewer treatments were needed with aflibercept compared with ranibizumab.
“In the patients who needed a lot of injections in the second year, they were more likely to be in the ranibizumab groups than in the aflibercept groups,” Kaiser said. “So an aflibercept user would feel comfortable with their choice.”
Except in second year data of the VIEW studies, the comparative results of aflibercept to ranibizumab are unknown, Dugel said.
“Eylea was not included [in most studies], and the results may not be fairly extrapolated to this drug,” he said. “So where does Eylea fit into all this? Frankly, we have no idea.”
Dugel said that the VIEW studies show aflibercept as non-inferior to ranibizumab in terms of efficacy. Second-year VIEW data show little difference between aflibercept and ranibizumab, he said.
“Eylea is marketed not as being more efficacious than Lucentis but rather more durable than Lucentis as the frequency of injections is slightly less,” Dugel said. “However, a closer look at the VIEW studies clearly shows that the playing field was not even in the first year of the study. In the second year of the study, when the playing field was more even, there was very little difference between the frequency of Lucentis and Eylea. Therefore, in my opinion, there seems to be very little difference between those drugs.” – by Matt Hasson