EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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EW RETINA 116 October 2014 by Tony Realini, MD, MPH Clinical trials are necessarily limited in duration, while AMD is a lifelong disease. Also, clinical trials typically enroll only 1 eye, while AMD is almost always bilateral. These aspects of clinical trial design can leave unanswered key questions that patients want answered: What will happen to me over the long term? Will I lose vision in my other eye? Post hoc analysis of the aflibe - cept VIEW study data has provided insight into these important clinical questions. Long-term outcomes The 1-year outcomes of the com- bined VIEW 1 and VIEW 2 phase 3 T he development of inhibi- tors to vascular endothelial growth factor (VEGF) has forever altered the thera- peutic landscape for a host of retinal vascular disorders includ- ing age-related macular degener- ation (AMD), as well as macular edema attributable to diabetes or retinal vein occlusion. These agents have the power to prevent vision loss and, in many cases, improve vision by reducing macular fluid. In clinical trials, more than 9 out of 10 patients remained stable during active treatment with the various agents, and approximately 3 in 10 saw visual acuity gains of 3 lines or more. studies of aflibe cept for neovascular AMD have been previously pub- lished. "These studies compared monthly dosing and every oth- er month dosing—after 3 initial monthly doses—of intravitreal aflibe cept with monthly ranibizum- ab," said Jean-François Korobelnik, MD, University of Bordeaux, France. "After 52 weeks, all treatment arms had similar visual, morphologic, and safety outcomes." These results were consistent through a total of 96 weeks as well. But what about long-term out- comes? "A subset of 323 patients from the VIEW 1 study were followed for up to an additional 112 weeks to fur- ther evaluate long-term safety and efficacy in patients with neovascular AMD," said Dennis Marcus, MD, Augusta, Ga. "These patients were enrolled in an open label rollover study, and during the extended follow-up, all patients were seen at least every 12 weeks." At each quarterly visit, patients received 2 mg aflibe cept injections and could receive them as frequent- ly as monthly if necessary. Following FDA approval of intravitreal aflibe - cept, the protocol was amended in June 2012 to require dosing every 8 weeks. Over an average follow-up of 112 weeks beyond the 96-week primary study endpoint, patients received an average of 12.9 additional intravitreal injections. In the primary VIEW study, the mean visual acuity gains of this cohort were +10.5 letters and +10.2 letters, respectively, at 52 and 96 weeks. By 208 weeks, the average visual acuity gain from baseline was +6.8 letters. "The visual acuity gains achieved by treatment with anti- VEGF therapy in VIEW 1 were largely maintained with continued treatment with intravitreal aflibe - cept 2 mg over a period of greater than 2 years," said Dr. Marcus. The 3- to 4-letter loss of acuity occurred gradually over time, sug- gesting that either the underlying disease worsened under treatment or possibly that treatment becomes less effective over time. A third possibil- ity is that quarterly evaluation and treatment may not be an adequate care process for neovascular AMD during the maintenance phase of therapy. The fellow eye AMD is almost always a bilateral disease, even though there may be asymmetry of both onset and severi- ty. If both eyes met eligibility criteria for the VIEW studies, the eye with the worse visual acuity was enrolled. If both eyes had active wet AMD, the untreated eye was the better eye. What happens to these fellow eyes over time? Dr. Korobelnik and colleagues have begun the process of evaluat- ing this issue in a post hoc analysis New insights from the VIEW studies of aflibe cept for AMD VII ÅÂÐÎ-ÀÇÈÀÒÑÊÀß ÊÎÍÔÅÐÅÍÖÈß ÏÎ ÎÔÒÀËÜÌÎÕÈÐÓÐÃÈÈ 27–29 àïðåëÿ 2015 ã. ÅÊÀÒÅÐÈÍÁÓÐÃ ÂÒÎÐÎÅ ÑÎÎÁÙÅÍÈÅ ÎÐÃÀÍÈÇÀÒÎÐ Åêàòåðèíáóðãñêèé öåíòð ÌÍÒÊ «Ìèêðîõèðóðãèÿ ãëàçà» ÎÐÃÊÎÌÈÒÅÒ Ðîññèÿ, 620149, ã. Åêàòåðèíáóðã, óë. Àêàäåìèêà Áàðäèíà, 4à Òåëåôîí: (343) 231-01-59 Ôàêñ: (343) 231-00-03 Å-mail: eakonauka@gmail.com www.eyeclinic.ru Äèñêóññèîííûå âîïðîñû ñîâðåìåííîé îôòàëüìîõèðóðãèè