Eyeworld

EW RETINA 120 Update from ASRS by Michelle Dalton EyeWorld Contributing Writer extend treatment times or treat only as needed. The study revealed other anom- alies: Patients with worse baseline vision (20/200 or worse) fared the best by 24 months, but virtually all other patients, with better baseline visual acuity, lost vision by the end of their follow-up periods. "This can't be explained by the number of injections alone," he said. "Patients with the best baseline visual acuity are particularly vulner- able to vision loss." The study also modeled pa- tient dropout from treatment and revealed that patients who drop out at 6 or 12 months fare much worse than those who maintain follow-up for 24 months. In fact, patients who drop out of treatment at the 6- or 12-month time point generally lose vision. "We do know that if patients aren't getting an immediate benefit or have lost more vision, they're apt not to return," Dr. Ciulla said. "This study underscores the need for physicians to emphasize the importance of more frequent treatment and careful follow-up for neovascular AMD, which is a chronic disease requiring chronic therapy," he said. Encapsulated cell therapy The promise of reduced treatment burden may not be realized any time The 2016 American Society of Retina Specialists (ASRS) meeting in San Francisco featured presentations on real-world outcomes conflicting with trial data, treatment costs, and how imaging is playing more of a treatment role F rom new instrumentation to make retina surgery more effective to new imaging modalities that are enabling retina specialists to identify abnormalities earlier to new devices designed to deliver treatments over a longer period, this year's American Society of Retina Specialists (ASRS) meeting was all about innovation and real-world outcomes, which are unfortunately not meeting outcomes found in the clinical trials. Age-related macular degeneration Several panels concentrated on wet age-related macular degeneration (AMD), and Thomas Ciulla, MD, MBA, Indianapolis, weighed in on the real-world outcomes of anti- vascular endothelial growth factor (VEGF) injections in the treatment and management of the disease. First, "many patients in our clinics have worse vision and/or more advanced disease than those in clinical trials on which we base treatment decisions," Dr. Ciulla said. "In the real world, patients do poor- ly," and practices are plagued with high dropout rates. In an analysis of the Vestrum Health Retina Research Database, which includes more than 750,000 retina patients, Dr. Ciulla said pa- tients who maintained follow-up for 24 months gained only two to four letters by month 24, compared to the eight to nine letters commonly cited in major prospective trials in- volving ranibizumab and aflibercept. Patients were included in the real-world outcome analysis only if they had already undergone three intravitreal injections within their first 4 months of treatment (any time between January 2011 and July 2013). At baseline, the average age was 82, and about 70% of patients first received off-label bevacizum- ab, with the remaining 30% evenly divided between ranibizumab and aflibercept, Dr. Ciulla said. "There are other issues for phy- sicians and patients that are not elu- cidated in the clinical trial data," he added, including that most patients need a family member for transpor- tation, which may adversely impact the number of visits (and therefore, injections) patients receive. "Previous studies have shown that if, during that first year, patients received fewer than five injections, patients will lose vision by the end of those first 12 months," he said. The real-world outcome analysis revealed that patients were gener- ally undertreated and performed worse than those patients in clinical trials. For example, patients in the 24-month cohort received about 12 injections, and patients in the 12-month cohort received about seven injections, instead of monthly treatment. This reflected real-world treat- ment regimens in the U.S., Dr. Ciulla said. The ASRS survey of members found more than 90% of specialists use OCT to determine whether or not patients need treatment. Once the patient is dry, most U.S. physicians soon, said Szilárd Kiss, MD, New York, as he presented disappoint- ing results on Cumberland, Rhode Island-based Neurotech's NT-503-3 encapsulated cell therapy (ECT). Al- though aspects of the Phase 2 study were successful—the device creates no apparent immune response, and it delivered a significantly higher level of the receptor than previous versions—in a direct comparison to determine non-inferiority to afliber- cept at 12 months, "the high rate of rescue event resulted in early study termination," Dr. Kiss said. "This was not a device fail- ure, but a device inadequacy," he stressed. At the time of study termina- tion, 26 subjects had been implant- ed (about 40% of the planned study enrollment). Patients were eligible for enrollment if they had received at least three previous injections of aflibercept with the last injection no more than 4 months earlier than en- rollment; had a best corrected visual acuity between 20/25 and 20/200; and had no or limited pathology that would negatively impact any vision gains. The ECT "did not produce enough anti-VEGF for this elderly patient population to stop the cho- roidal neovascularization," Dr. Kiss said, noting the detected levels were below the theoretical 48 micrograms necessary. "However, the histology con- firmed none of the subjects had any unexplained inflammation or cell death," he said. "There was good cell viability and stability out to many months." Both theoretical modeling and animal studies had suggested higher levels of anti-VEGF would be delivered with the therapy. Dr. Kiss was commended for presenting negative findings by the panel, which also reiterated the difficulty of moving beyond animal studies into human trials. Diabetic macular edema/ diabetic retinopathy Optical coherence tomography (OCT) angiography "can help phy- sicians visualize the status of retinal vascular perfusion at various depths in the retina and enables grading of pathology in retinal diseases, and September 2016 Wet AMD Source: Karl Brasse, MD

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