Abstract
Purpose: :
The primary objectives are evaluate visual acuity (VA) and ocular tomography coherence (OCT) changes with the use of 2.5 mg of intravitreous bevacizumab (IVB) every six weeks in the treatment of diabetic macular edema (DME). The secondary objective is to evaluate the safety of the procedure.
Methods: :
Open -label, prospective, non-randomized, non-controlled, interventional case series study. Patients with DME and VA < 20/40 were enrolled. Patients received four IVB injections, 45 days apart, under sterile conditions. VA was measured using the ETDRS chart at baseline, 90-day, and 180-day. Fluorescein angiogram (FA) and OCT were performed at baseline and during the follow-up visits. Main exclusion criteria were follow-up less than 90 days, hard exudates plaque in fovea, use of intraocular or periocular steroids or intraocular surgery 6 months or less prior to the study entry, macular laser photocoagulation 3 months or less prior IVB, proliferative diabetic retinopathy, history of thromboembolic event in the past 6 months.
Results: :
: Eleven eyes (9 patients) were enrolled. Five were male. The mean age was 59.9 years (53 -70). Mean HbA1c was 7, 58% (SD: 2.87). The mean VA was 15.5 ETDRS letters (SD: 11.28), 14.9 letters (SD: 12.6), and 19.2 letters (SD: 16.1) at baseline, 90-day visit and 180-day visit, respectively. The mean OCT macular thickness was 383.4 µ (SD: 146.6 µ), 405.5 µ (SD: 117.8 µ), and 426.2 µ (SD: 118.0 µ) at baseline, 90-day, and 180-day follow-up visit, respectively. No ocular or systemic adverse effects were recorded during the study period.
Conclusions: :
VA remained stable or slightly improved with the use of 2.5 mg of IVB every six weeks, despite of the increase in the macular thickness measured with the OCT. Although the use of IVB was safe during the study period, according to our small study, it did not improved visual prognosis in diabetic macular edema.
Keywords: diabetic retinopathy • edema • vascular endothelial growth factor