Abstract
Purpose: :
To evaluate the efficacy of intraocular injections with bevacizumab in patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
Methods: :
Prospective, randomized, sham injection-controlled, double masked clinical trial. 60 patients with ME secondary to CRVO. At baseline, patients were randomized 1:1 to receive intraocular injections of bevacizumab or sham injections every 6 weeks for 6 months.
Results: :
At the end of follow up 18/30 (60.0%) patients in the study group had gained ≥ 15 letters compared to 6/30 (20.0%) patients in the control group (p=0.003). At 6 weeks there was an improvement of BCVA compared to baseline by a mean of 7.5 letters in the study group. The BCVA further improved by 11.4 letters at 12 weeks, 13.9 letters at 18 weeks and 14.1 letters at 24 weeks. In the control group the BCVA decreased by 0.3, 3.9, 3.2 and 2.0 letters at 6, 12, 18 and 24 weeks respectively. The difference in BCVA between the treatment groups was statistically significant from 12 weeks and beyond (p<0.003). The mean decrease in central retinal thickness (CRT) was significantly greater in the study group (426 μm) than in the control group (102 μm) at all time points up to week 24 (p<0.001). No residual edema, defined as CRT of less than 300 μm at 24 weeks, was found in 26/30 (86.7%) patients in the treatment group as compared to 6/30 (20%) patients in the control group (p<0.001). In the sham group, 6/30 (20%) patients had developed iris rubeosis at week 24. No patients in the study group had rubeosis at week 24 (p=0.052). There were no events of endophthalmitis, retinal tear or retinal detachment during the 24 weeks treatment period. No serious non-ocular adverse events were reported.
Conclusions: :
Intraocular injections of bevacizumab given every 6 weeks for 6 months improves visual acuity and reduces ME significantly compared to sham.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00906685
Keywords: vascular occlusion/vascular occlusive disease • edema • vascular endothelial growth factor