|Bevacizumab for Neovascular Age-related Macular Degeneration in China|
|Li, Xiaoxin1,2; Hu, Yonghua4; Sun, Xiaodong3; Zhang, Junjun5; Zhang, Maonian6; Neovasc Age-Related Macular Degene1|
|WOS标题词||Science & Technology|
|关键词[WOS]||POLYPOIDAL CHOROIDAL VASCULOPATHY ; INTRAVITREAL INJECTION ; AVASTIN THERAPY ; RANIBIZUMAB ; PHARMACOKINETICS ; SAFETY|
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 mu m in regimen A and 60 mu m 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).
|资助机构||National Key Technology Research and Development Program in the 11th Five-Year Plan of China|
|作者单位||1.Minist Educ, Key Lab Vis Loss & Restorat, Beijing, Peoples R China|
2.PLA, Dept Ophthalmol, Gen Hosp, Beijing, Peoples R China
3.Peking Univ, Dept Ophthalmol, Peoples Hosp, Beijing 100044, Peoples R China
4.Shanghai Jiao Tong Univ, Dept Ophthalmol, Shanghai Peoples Hosp 1, Shanghai 200030, Peoples R China
5.Peking Univ, Sch Publ Hlth, Beijing 100044, Peoples R China
6.Sichuan Univ, Dept Ophthalmol, W China Hosp, Chengdu 610064, Peoples R China
|Li, Xiaoxin,Hu, Yonghua,Sun, Xiaodong,et al. Bevacizumab for Neovascular Age-related Macular Degeneration in China[J]. OPHTHALMOLOGY,2012,119(10):2087-2093.|
|APA||Li, Xiaoxin,Hu, Yonghua,Sun, Xiaodong,Zhang, Junjun,Zhang, Maonian,&Neovasc Age-Related Macular Degene.(2012).Bevacizumab for Neovascular Age-related Macular Degeneration in China.OPHTHALMOLOGY,119(10),2087-2093.|
|MLA||Li, Xiaoxin,et al."Bevacizumab for Neovascular Age-related Macular Degeneration in China".OPHTHALMOLOGY 119.10(2012):2087-2093.|