- 作者：Xiaoxin Li ; Yonghua Hu ; Xiaodong Sun ; Junjun Zhang ; Maonian Zhang ; Neovascular Age-Related Macular Degeneration Treatment Trial Using Bevacizumab (NATTB)
- 刊名：Ophthalmology
- 出版年：2012
- 出版时间：October, 2012
- 年：2012
- 卷：119
- 期：10
- 页码：2087-2093
- 全文大小：1743 K
Objective
To evaluate 2 different dosing regimens of intravitreal bevacizumab for the treatment of neovascular age-related macular degeneration (AMD) patients in China.Design
Multicenter, randomized, prospective, open-label clinical trial.
Participants
One hundred eighty-five patients with active neovascular AMD, exclusion of a macular scar, choroidal neovascularization not resulting from AMD, and polypoidal choroidal vasculopathy.
Intervention
Patients were assigned randomly to receive intravitreal injections of bevacizumab every 6 weeks for the first 3 injections followed by injections every 6 weeks (regimen A, n = 91) or every 12 weeks (regimen B, n = 94).
Main Outcome Measures
The primary outcome measure was a comparison of the mean change in visual acuity from baseline. The secondary outcome measure was a comparison of the proportion of patients with a change in visual acuity of 15 letters or more. Adverse events were monitored.
Results
One-hundred eighty five patients were enrolled. At 48 weeks, the increase in the mean visual acuity measurements from baseline were 12.58 letters in regimen A and 10.06 letters in regimen B (P = 0.288). At 48 weeks, the percentage of eyes losing fewer than 15 letters was 96.2 % in regimen A and 93.9 % in regimen B (P = 0.720). At 48 weeks, the median decrease in central retinal thickness measurements from baseline was 119 ¦Ìm in regimen A and 60 ¦Ìm in regimen B (P = 0.221). Adverse events during the 48 weeks included anterior chamber inflammation in 17 patients (18.7 % ) from regimen A and 9 patients (9.6 % ) from regimen B (P = 0.075). There were no other notable ocular adverse events in either group.
Conclusions
Intravitreal bevacizumab improved visual acuity and decreased macular thickness in patients with neovascular AMD when dosed either every 6 weeks or every 12 weeks after 3 doses given at 6-week intervals. Although there were no statistically significant differences between the 2 regimens, the results tended to favor the group dosed every 6 weeks (regimen A).
Financial Disclosure(s)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.