- 作者：Laurent Kodjikian ; Eric H. Souied ; G¨¦rard Mimoun ; Martine Mauget-Fa?sse ; Francine Behar-Cohen ; Evelyne Decullier ; Laure Huot ; Gilles Aulagner ; GEFAL Study Group
- 刊名：Ophthalmology
- 出版年：2013
- 出版时间：November, 2013
- 年：2013
- 卷：120
- 期：11
- 页码：2300-2309
- 全文大小：769 K
Objective
To evaluate the relative efficacy and safety profile of bevacizumab versus ranibizumab intravitreal injections for the treatment of neovascular age-related macular degeneration (AMD).Design
Multicenter, prospective, noninferiority, double-masked, randomized clinical trial performed in 38 French ophthalmology centers. The noninferiority limit was 5 letters.
Participants
Patients aged ¡Ý50 years were eligible if they presented with subfoveal neovascular AMD, with best-corrected visual acuity (BVCA) in the study eye of between 20/32 and 20/320 measured on the Early Treatment of Diabetic Retinopathy Study chart and a lesion area of less than 12 optic disc areas (DA).
Methods
Patients were randomly assigned to intravitreal administration of bevacizumab (1.25 mg) or ranibizumab (0.50 mg). Hospital pharmacies were responsible for preparing, blinding, and dispensing treatments. Patients were followed for 1 year, with a loading dose of 3 monthly intravitreal injections, followed by an as-needed regimen (1 injection in case of active disease) for the remaining 9 months with monthly follow-up.
Main Outcome Measures
Mean change in visual acuity at 1 year.
Results
Between June 2009 and November 2011, 501 patients were randomized. In the per protocol analysis, bevacizumab was noninferior to ranibizumab (bevacizumab minus ranibizumab?+1.89 letters; 95 % confidence interval [CI],??1.16 to?+4.93, P?<?0.0001). The intention-to-treat analysis was concordant. The mean number of injections was 6.8 in the bevacizumab group and 6.5 in the ranibizumab group (P?= 0.39). Both drugs reduced the central subfield macular thickness, with a mean decrease of 95 ¦Ìm for bevacizumab and 107 ¦Ìm for ranibizumab (P?= 0.27). There were no significant differences in the presence of subretinal or intraretinal fluid at final evaluation, dye leakage on angiogram, or change in choroidal neovascular area. The proportion of patients with serious adverse events was 12.6 % in the bevacizumab group and 12.1 % in the ranibizumab group (P?=?0.88). The proportion of patients with serious systemic or ocular adverse events was similar in both groups.
Conclusions
Bevacizumab was noninferior to ranibizumab for visual acuity at 1 year with similar safety profiles. Ranibizumab tended to have a better anatomic outcome. The results are similar to those of previous head-to-head studies.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.