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A. C. Ho, H. Yue, L. Wilson; Ranibizumab in Wet Age-Related Macular Degeneration (AMD): Crossover/ Rollover Patient Results in PIER Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):268.
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PIER–a 2-year, phase IIIb, multicenter, randomized, double-masked, sham-controlled study of ranibizumab (Lucentis®) for treatment (Tx) of neovascular (wet) AMD–examined whether ranibizumab dosed monthly for 3 mo, then once every 3 mo, prevented visual acuity (VA) loss. After primary efficacy analyses at month 12 showed ranibizumab superiority to sham Tx, the protocol was amended to allow crossover from sham to active Tx, and later to allow rollover from quarterly to monthly ranibizumab dosing.
The Tx schema shows the randomization (in 2005) and the amendments. VA (letters) was assessed using ETDRS charts at 4 meters. Safety was assessed based on adverse events.
Of 40 eligible sham-group patients (pts), 39 crossed over. Mean VA continued to decrease, by 5.8, 1.4, 5.8, and 3.5 letters at 1, 3, 9, and 10 mo, respectively, after the first crossover Tx. Mean VA for pts in the 0.3- and 0.5-mg dose groups who rolled over to monthly 0.5-mg Tx increased by 1.6 and 1.8 letters, respectively, at month 1, then increased to a gain of 2.2 and 4.1 letters, respectively, at month 4 after the first rollover Tx. Mean VA for sham-group pts who rolled over to monthly ranibizumab decreased by 2.6 letters at month 1, then was almost constant over time, with a loss of 2.2 letters at month 4 after the first rollover Tx. More sham-group rollover pts than ranibizumab pts had dry lesions at month 24. No new safety issues emerged after sham-group pts crossed to ranibizumab.
Sham-group pts after longstanding untreated AMD (mean, 14 months) did not show a VA response when treated with ranibizumab (quarterly, then monthly), whereas ranibizumab-group pts who rolled over to monthly ranibizumab treatment still had lesions capable of VA gain.
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