November 10, 2014
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Anti-VEGF therapy for AMD inconsistently managed worldwide in real-life practice

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Anti-VEGF therapy for age-related macular degeneration has been a major breakthrough in the battle against vision loss. The pivotal MARINA and ANCHOR trials showed a mean increase of 7 to 11 visual acuity letters at 1 year, substantially maintained at 2 years, with monthly injections of ranibizumab. In clinical trial settings, optical coherence tomography-guided variable-dosing regimens achieved comparable results. In the VIEW trials, after three monthly loading doses, bimonthly administration of aflibercept produced similar improvement to monthly ranibizumab.

However, both the HORIZON and SEVEN-UP studies, which observed over the long term MARINA and ANCHOR trial patients, showed evidence that less rigorous follow-up patterns, with Lucentis (ranibizumab, Genentech) administered at the investigator’s discretion, led to a decline of the visual acuity gains achieved with monthly treatment. In the real world, as shown by numerous reports across continents, anti-VEGF treatment does not meet expectations and results are not up to the standards of clinical trials.

Such a discrepancy is obvious, simply because clinical trials are not a real-world situation, according to Jay S. Duker, MD, OSN Retina/Vitreous Board Member.

“Trials recruit a select motivated group of patients, and typically those patients get the opportunity to receive a treatment that they could not get otherwise. There are exclusion criteria, which prevent people with certain diseases or people who are sick or unable to comply with a strict follow-up schedule to be enrolled. This highly selected group of relatively healthy subjects are not the real world,” he said.

Click here to read the full cover story, published in Ocular Surgery News U.S. Edition, November 10, 2014.