Intravitreal Bevacizumab vs. Combination of Intravitreal Bevacizumab plus Macular Photocoagulation in Clinically Significant Diabetic Macular Edema: 6 months Results of a Randomized Clinical Trial

To compare the 6-months anatomic and best corrected visual acuity (BCVA) responses after primary intravitreal bevacizumab (IVB; intravitreal AVASTIN) and IVB plus macular photocoagulation (MPC) in diabetics with clinically significant macular edema (CSME) In this interventional Randomized Clinical Trial (RCT) 40 diabetics (80 eyes) with bilateral CSME and non-proliferative diabetic retinopathy (NPDR) or early proliferative diabetic retinopathy (PDR) underwent IVB in one eye (group A) and IVB plus MPC in the other eye (group A+MPC). The patients had a complete eye exam (including BCVA, OCT and fluorescein angiography (F/A)) at baseline and were re-examined every two months for 6 months BCVA and OCT indices and number of IVB injections were recorded. Main outcome measures were number of IVB injections and changes in BCVA and OCT. In both groups, the mean BCVA [(group A: 0.326±0.279 logMAR±SD before treatment and 0.188±0.245 logMAR±SD at 6 months), (group A+ MPC 0.409±0.332 logMAR±SD baseline and 0.230±0.273 logMAR±SD at 6 months)] and OCT indices [(group A: 261±115 µ before treatment and 221±87 µ Mean±SD at 6 months), (group A+ MPC: 270±93 µ baseline and 225±80 µ Mean±SD at 6 months)] improved at the final follow-up and these changes were statistically significant; however there was no significant difference between the two groups at baseline and the final visit at 6 months follow-up. There was also no statistically significant difference in number of IVB injections between the two groups (group A: 2.3±1.24 and group A± MPC: 2.49±1.09). IVB injection is an effective modality of treatment in CSME, but MPC appears to have no additive effect on it, at least in the first 6 months of treatment.