- 作者：Ursula Schmidt-Erfurth ; Peter K. Kaiser ; Jean-Fran莽ois Korobelnik ; David M. Brown ; Victor Chong ; Quan Dong Nguyen ; Allen C. Ho ; Yuichiro Ogura ; Christian Simader ; Glenn J. Jaffe ; Jason S. Slakter ; George D. Yancopoulos ; Neil Stahl ; Robert Vitti ; Alyson J. Berliner ; Yuhwen Soo ; Majid Anderesi ; Olaf Sowade ; Oliver Zeitz ; Christiane Norenberg ; Rupert S ; brink ; et al.
- 刊名：Ophthalmology
- 出版年：January, 2014
- 年：2014
- 卷：121
- 期：1
- 页码：193-201
- 全文大小：666 K
Purpose
To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period.Design
Two randomized, double-masked, active-controlled, phase 3 trials.
Participants
Two thousand four hundred fifty-seven patients with neovascular AMD.
Methods
From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks.
Main Outcome Measures
Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA.
Results
Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of聽鈭?.64 [95% CI,聽鈭?.89 to聽鈭?.40] and聽鈭?.55 [95% CI,聽鈭?.79 to聽鈭?.30]; P鈥?lt;鈥?.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week聽96.
Conclusions
All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96聽weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing.