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

Purpose: 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) Methods: 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. Results: 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). Conclusion: 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.