Purpose:
To evaluate the safety and efficacy of 12-month intravitreal bevacizumab therapy for diabetic macular edema (DME) in a "real-world" clinical setting.
Methods:
A retrospective chart review of eyes affected by DME and treated with intravitreal bevacizumab (1 mg) for 12 months was conducted. This study included patients referred to our department between January 2010 and March 2010 and affected by DME requiring intravitreal bevacizumab treatment at physician discretion based on fluorescein angiography, clinical appearance and spectral domain optical coherence tomography (OCT). Patients received an injection at baseline and were then followed-up with BCVA measurement, complete ophthalmologic evaluation and OCT imaging. Re-treatment was performed at investigator discretion. Rescue treatment with macular laser photocoagulation was recorded. The primary efficacy outcome was change in best corrected visual acuity (BCVA, logMAR). Secondary outcomes include the incidence of ocular and non-ocular adverse events, the number of injections required during the follow-up and the number of monitoring visits performed.
Results:
The study included 55 consecutive eyes of 43 patients. "Real world patients" differed significantly from those of large randomized trials. Baseline and follow-up findings are detailed in Figure 1. BCVA improved on average by -0.03 ±0.19 logMAR (Figure 1). No adverse events were reported.
Conclusions:
VEGF inhibition in the treatment of DME with a pro-re-nata regimen in a real world clinical setting resulted in less favorable outcomes than reported in controlled clinical trials. Our picture of real world experience may be influenced by the baseline characteristics of the studied population which significantly differed from that of large randomized trials and by the loose regimen applied in this real world scenario. Mean BCVA was stable during 12-months of follow-up with an average of 2.2 injections. In conclusion, results from sponsored trials may not entirely apply to real-world DME population and PRN regimens with strict follow-up may be difficult to achieve. Alternative treatments and follow-up regimens more easily applicable in real world clinical settings should be explored.
Keywords: diabetic retinopathy • macula/fovea • vascular endothelial growth factor