Abstract
Purpose: :
The primary objective is to evaluate the safety of the intravitreal bevacizumabe (IVB) associated to macular photocoagulation in the treatment of macular edema secondary to CRVO. The secondary objective is to evaluate the number of injections needed.
Methods: :
This is a phase I non comparative, consecutive, single-arm study of patients with macular edema secondary to CRVO. All patients were submitted to a complete ophthalmological examination, including best-corrected ETDRS visual acuity (BCVA), slit-lamp biomicroscopy, intraocular pressure (IOP) and fundus examination. Fluorescein angiography (FA) and OCT central macular thickness (CMT) measurements were also performed. Patients were seen at baseline, one and seven days after the injections, and every 4 weeks thereafter. FA and OCT were performed at baseline, D30, D60, D90, D120, D150 and D180. A minimum of three consecutive injection four weeks apart up to a maximum of six injections were given until OCT CMT reaches 250 µm or less. Laser photocoagulation was performed 4 weeks after CMT goal. Main inclusion criteria: eyes with macular edema; BCVA ≤ 20/40 and ≥ 20/800 in the study eye and ≥20/40 in the fellow eye; age ≥ 50 years old and OCT ≥ 250 µm. Main exclusion criteria: intraocular pressure ≥ 24 mmHg, iris, angle or fundus neovascularization; CRVO < 3 months or > 12 months, use of any intravitreous drug in the past 3 months.
Results: :
Six eyes of six patients (4 women and 2 men) were enrolled. Baseline results: mean BCVA was 0.81 logMar (range, 0.4 - 1.0) and CMT was 490 µm (range, 288 - 600 µm). Mean age was 62.4 years-old (range, 50-78). Five were caucasians and 1 was black. Last follow-up results: mean BCVA was 0.6 logMar (range, 0.4 - 0.8) and CMT was 289 µm (range, 233 -396 µm). IOP was within the normal limits throughout the follow-up period. FA didn’t show development of retinal ischemia. No ocular or systemic adverse effects were recorded during the study period.
Conclusions: :
The use of intravitreal bevacizumab associated with macular photocoagulation showed no ocular or systemic adverse effects. VA has improved and CMT measured by OCT has decreased.
Clinical Trial: :
www.irct.ir, IRCT20101129527N1
Keywords: vascular occlusion/vascular occlusive disease • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • drug toxicity/drug effects