Abstract
Purpose:
: To evaluate the efficacy and safety of the combination of intraocular injections of ranibizumab and selective laser photocoagulation of peripheral retinal areas of capillary non-perfusion in patients with macular edema due to central retinal vein occlusion (CRVO).
Methods:
: The prospective, proof-of-concept study randomized 22 CRVO patients into 2 arms. The experimental group (ranibizumab+laser; n=10) received intravitreal ranibizumab with additional laser photocoagulation; the control group (n=12) was treated with ranibizumab only. All patients received 3 initial ranibizumab injections (loading phase) followed with the pro re nata (PRN) regimen according to pre-defined criteria. The changes in the Best Corrected Visual Acuity (BCVA) using the ETDRS charts (primary endpoint) and central retinal thickness (CRT) were documented until 10 months after randomization. Means/ medians of the between-group differences with corresponding 95% confidence limits were estimated. Furthermore, the proportion of subjects with d neovascularizations developed and the number and kind of adverse events (AEs) were evaluated.
Results:
Patients treated with ranibizumab and laser improved from BCVA=61.6±12.7 ETDRS letters at baseline to 72.5±11.5 letters on month 10. In the control group improvement from 58.6±12.4 to 64.5±17.2 ETDRS letters was observed. CRT decreased between baseline and 10 months’ visit in the experimental group from 560.6±247.4 µm to 267.4±93.7 µm and in the control group from 696.0±212.9 µm 282.5±175.0 µm. More pronounced improvements in BCVA change were seen in the index arm in descriptive statistics although all observed group differences were not significant due to small samples. No patient in the experimental group and 2 patients in the control arm developed neovascularizations of retina requiring the rescue scatter laser photocoagulation.
Conclusions:
The selective laser photocoagulation of peripheral areas of capillary non-perfusion seems to lead to additional visual improvement in patients with CRVO treated with ranibizumab. A replication trial with larger patient samples is necessary to enhance existing evidence and confirm the results of this proof-of-concept study.
Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
578 laser •
748 vascular endothelial growth factor