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Clinical practice, study protocols for treating AMD with anti-VEGF injections vary widely
Study finds real-life practices administer fewer injections and OCT exams.
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When it comes to the clinical monitoring of patients with neovascular age-related macular degeneration who are treated with intravitreal anti-VEGF injections, real-life practice falls short in injection frequency compared with clinical trials.
“There is this concept that the clinical trials provide patients with a great improvement in visual acuity in the settings of age-related macular degeneration, diabetic macular edema and retinal vein occlusion,” Szilárd Kiss, MD, said. “These great results, however, derive from frequent patient monitoring visits, as well as frequent intravitreal injections.”
Kiss was the lead author of a study in Ophthalmic Surgery, Lasers and Imaging Retina that compared real-world monitoring of AMD patients with those of the phase 3 clinical trials for Avastin (bevacizumab, Genentech) and Lucentis (ranibizumab, Genentech), including CATT, MARINA and ANCHOR, whose study protocols were monthly intervals for ophthalmic visits, optical coherence tomography exams and anti-VEGF injections.
Szilárd Kiss
Based on claims data
To determine clinical practice management, the retrospective cohort study relied on administrative claims data from the IMS Health LifeLink Health Plan, covering the years 2008 to 2011. Patient criteria were newly diagnosed neovascular AMD cases with at least one intravitreal bevacizumab or ranibizumab injection, for a total of 8,811 and 2,877 patients, respectively.
The claims data showed that the mean annual number of ophthalmic visits was low, ranging from 6.8 to 8.7. Even lower was the mean annual number of OCT exams, which ranged from 4.8 to 6.7. Not surprisingly, the mean annual number of anti-VEGF injections ranged from 4.5 to 6.8.
“The challenge of real-life practice is twofold: Patients committing to monthly office visits and actually treating them monthly,” Kiss told Ocular Surgery News.
A major barrier to monthly visits is the time required, typically 1 to 2 hours.
“Many macular degeneration patients are elderly and often need to be accompanied to the office by someone else,” Kiss said. “Therefore, fewer patient visits equate fewer injections.”
Because patients are being injected on average four to seven times a year — with perhaps a cluster of three monthly injections initially, followed by several months before a fourth or fifth injection — “this results in a visual acuity gain that is 50% less than with monthly injections,” Kiss said, noting that he encourages clinicians to let patients know the greatly improved visual acuity they can expect with monthly injections.
Kiss said he is surprised by the degree that clinicians in everyday practice deviate from the pivotal clinical trials.
“We have a lot to do to educate physicians just how much undertreatment there is,” he said. “Patients also need to be educated about the consequences of that undertreatment.”
EMR data
Kiss and colleagues are evaluating OCT data and real-world visual outcomes for anti-VEGF injections in treating AMD, DME and RVO by culling the electronic medical records of large health care systems instead of using large insurance databases that preclude functional outcome.
“Preliminary results are that the number of injections is consistent with what we saw with the database studies: undertreatment,” Kiss said. “The visual acuity gains are also a fraction of what was seen in the clinical trials.”
Kiss is hopeful, however, that future treatments for AMD that require less frequent injections but are longer lasting, such as the ankyrin repeat protein DARPin (Allergan) or gene therapy, will achieve the same visual acuity results as monthly injections. – by Bob Kronemyer