Intravitreal ranibizumab (lucentis) for the treatment of diabetic macular edema: a systematic review and meta-analysis of randomized clinical control trials.

PURPOSE

To evaluate the therapeutic effect and safety of intravitreal ranibizumab (RBZ) or RBZ combined with focal/grid laser in diabetic macular edema (DME).

DESIGN

Systematic review of randomized clinical control trials (RCCTs) comparing RBZ or RBZ combined with focal/grid laser to non-drug control or focal/grid laser in DME was performed.

METHODS

The RCCTs in Cochrane Central Register of Controlled Trials, PUBMED, EMBASE, the metaRegister of Controlled Trials, and ClinicalTrials.gov were included. The means and standard deviations of change from baseline in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were extracted at 12 or 24 months. Data regarding complications were collected. The Review Manager 5.1.2 was used.

RESULTS

Four trials with a total of 1313 DME patients were included. Our analysis showed that intravitreal RBZ appeared to be superior to non-drug therapy in reducing CMT (12 months, p = 0.02), and improving BCVA with statistical significance (12 months, p = 0.0003). RBZ combined with focal/grid laser experienced statistically significant reduction in CMT (12 months, p = 0.01), and improvement in BCVA (12 months, p < 0.00001; 24 months, p = 0.007) compared with focal/grid laser. The incidence of adverse events (AEs) had no statistical difference between RBZ monotherapy or RBZ combined with laser and the noninvasive interventions. The improvement in BCVA and CMT from the RBZ and RBZ plus laser arms both had no statistically significant difference. While the mean number of intravitreal injections needed was lower in RBZ plus laser arm than RBZ arm at the end of 24 months.

CONCLUSIONS

Our analysis shows that RBZ and RBZ combined with focal/grid laser is more advantageous than non-drug treatment or focal/grid laser in reducing CMT and improving BCVA in DME during 12 and 24 months follow-up period and can be well tolerated based on the safety assessment. Intravitreal RBZ may be equivalent to RBZ combined with focal/grid laser.