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Algorithm may guide treat-and-extend anti-VEGF regimens for retinal disease
Treatment can be extended by up to 2 weeks if the disease remains stable and fluid is stabilized or eliminated.
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A new algorithm may be used to tailor treat-and-extend intravitreal anti-VEGF therapy to individual patients with retinal disease, according to a study.
An international group of retina specialists reviewed the literature on treat-and-extend regimens and devised the algorithm based on study data and clinical experience.
The algorithm may help clinicians reduce the treatment burden and cost associated with fixed monthly or as-needed injection protocols, the study authors said in Retina.
“There seems to be accumulating evidence that the treat-and-extend regimen does seem to offer similar visual benefits to the other regimens, so it seems to be a viable alternative that seems to offer promising visual outcomes. Also, it’s something that can be sustained sometimes more easily than having patients come in monthly year after year,” K. Bailey Freund, MD, the corresponding author, told Ocular Surgery News.
Treat-and-extend regimens
A consensus panel developed the algorithm using data from 11 published studies on treat-and-extend regimens with intravitreal Avastin (bevacizumab, Genentech), Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron).
“Prior to this publication, there was some confusion as to what treat-and-extend really meant. For instance, do you first need to give a loading dose before you go on to treat-and-extend, like a sequence of monthly treatments?” Freund said. “As a result of the meetings, we were able to come up with a consensus recommendation and flow chart of what treat-and-extend meant and how to implement that.”
The treat-and-extend approach used in most of the studies involved a 3-month loading scheme until no fluid was detected on spectral-domain OCT, followed by 2-week extension intervals up to a maximum of 10 to 12 weeks unless fluid or hemorrhage recurred.
“Right now, spectral-domain OCT seems to be what most retina specialists are using to look at the anatomy in patients with these retinal diseases. Not only treat-and-extend, but PRN or OCT-guided approaches are so dependent on looking at the anatomy,” Freund said.
Based on clinical experience, the treat-and-extend algorithm would be applicable to wet AMD, macular edema secondary to retinal vein occlusion and diabetic macular edema.
“Just by looking at the manuscript, one can see how we felt that treat-and-extend could be applied to everyday practice, which is treating until you reach what we define as a maximal response and then how to go on from there in terms of extending the interval between injections a week or two at a time until you sort of get to your comfort zone in terms of the maximal extension,” Freund said.
Extending and shortening the interval
Using the algorithm, the consensus panel determined that treatment can be extended by up to 2 weeks if the disease remains stable.
“I think whether to go 1 or 2 weeks depends on what you feel is the risk of extending too quickly,” Freund said. “For instance, if you think this patient might develop a sudden hemorrhage if they are extended too rapidly, that might be someone you extend more slowly. If you think that that risk is very low, then you can extend more quickly.”
The injection interval should be shortened by 1 to 2 weeks for minor recurrences of fluid or slight increases in previously stable fluid, especially when these changes coincide with visual loss of less than six letters or the appearance of small extrafoveal subretinal hemorrhage, even when it does not involve vision loss.
If deterioration is severe, with major recurrences of fluid or previously stable fluid, especially when accompanied by a visual loss of six or more letters, any subfoveal hemorrhage or large extrafoveal macular hemorrhage, the patient should be re-evaluated and fluorescein angiography or indocyanine green angiography may be needed. In cases of severe deterioration, re-introduction of monthly injections may be contemplated.
“As far as when you might want to go back to monthly injections, we define a minor recurrence or a major recurrence,” Freund said. “If a patient with macular degeneration were to suddenly develop a large hemorrhage or a big increase in exudation, then you probably want to go back to monthly treatment, basically start all over again. You wouldn’t want to just say, ‘We’ve been doing 10 weeks, so we’ll just go back to 9 or 8 weeks.’ You probably want to be more aggressive and treat monthly until everything appears stable again before you consider trying to extend that interval again.” – by Matt Hasson
- Reference:
- Freund KB, et al. Retina. 2015;doi:10.1097/IAE.0000000000000627.
- For more information:
- K. Bailey Freund, MD, can be reached at Vitreous-Retina-Macula Consultants of New York, 460 Park Ave., 5th Floor, New York, NY 10022; email: kbfnyf@aol.com.
Disclosure: Freund reports he is a consultant for Genentech, Bayer HealthCare, Heidelberg Engineering and Optovue.
Perspective
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Andrew P. Schachat, MD
Freund and colleagues discuss an important topic. The diseases they discuss are common, and there are treatment options that range from monthly injections with approximately $2,000 drugs to periodic injections with an approximately $25 to $75 drug. How should patients be managed? The authors offer consensus recommendations concerning treat-and-extend regimens. We prefer guidance from multiple large and well-done randomized comparative trials. Consensus recommendations offer second-tier guidance, albeit from very smart leaders in our field.
Treat-and-extend regimens make sense they allow fewer visits and injections so they are convenient and predictable. For age-related macular degeneration, there is ample data to support a treat-and-extend management plan, including guidance from randomized trials. But one of the randomized controlled trials is a pilot study (reference 18 in the Freund study), and the large and more definitive randomized controlled trial, the LUCAS trial (reference 23 in the Freund study), randomizes to treat-and-extend ranibizumab vs. treat-and-extend bevacizumab and not with one or more of the anti-VEGF drugs randomized to, for example, as needed vs. treat-and-extend.
Well-done randomized controlled trials have demonstrated the efficacy and safety of monthly and as-needed anti-VEGF drugs to treat wet AMD. I believe there is ample evidence to use a treat-and-extend strategy for wet AMD as well. As Freund and colleagues wrote, The consensus panel found the evidence for TER in ME/RVO and DME too scarce to provide general guidance at present. While I think it is very reasonable to use a treat-and-extend approach for non-AMD indications, we should do so with the knowledge that there is much less evidence than for the AMD indication.
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