Glenn J Jaffe, Briana Cameron, Giulio Barteselli, Natalia Callaway, Cindy Skalak, John Choong, Shamika Gune
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引用次数: 0
Abstract
Purpose: To compare the development of macular atrophy (MA) in eyes treated with the Port Delivery System with ranibizumab (PDS) with those treated with monthly intravitreal ranibizumab injections in the Archway trial.
Design: Preplanned exploratory analysis of a phase 3, open-label, randomized trial.
Participants: Patients with neovascular age-related macular degeneration (nAMD) diagnosed within 9 months of screening, previously treated with and responsive to anti-vascular endothelial growth factor therapy.
Methods: Eyes were randomized 3:2 to treatment with the PDS 100 mg/mL with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5 mg injections every 4 weeks (monthly ranibizumab).
Main outcome measures: Prevalence, incidence, and progression of MA.
Results: The analysis population consisted of 415 eyes (248 and 167 eyes in the PDS Q24W and monthly ranibizumab arms, respectively). At study baseline, MA was observed in 22.3% (PDS Q24W) and 20.4% (monthly ranibizumab) of eyes. At week 96, prevalence of MA was 39.1% and 39.2% while incidence of new MA in eyes without MA at baseline was 20.0% and 22.6% in the PDS Q24W and monthly ranibizumab arms, respectively. In eyes without baseline MA, mean MA area at week 96 was 0.4 in the PDS Q24W arm and 3.8 mm2 in the monthly ranibizumab arm with a difference of 3.4mm2, (P = 0.054) favoring PDS. In eyes with baseline MA, mean change in MA area from baseline to week 96 was +2.2 mm2 for both the PDS Q24W and monthly ranibizumab arms.
Conclusions: In the Archway trial, which compared PDS Q24W with monthly ranibizumab injections for nAMD treatment over 2 years, prevalence and incidence of MA were similar between arms over the study duration. In eyes without baseline MA, PDS-treated eyes had less MA area by 3.4 mm2, a potentially clinically meaningful (although not statistically significant) difference. The results of this prespecified exploratory analysis suggest that PDS treatment is not associated with higher incidence or progression of MA when compared with monthly injections of ranibizumab. In eyes without baseline MA, the progression of atrophy area was 4 times less in PDS-treated eyes. Additional studies could further elucidate this observation.
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