Efficacy and Safety of Ranibizumab Intravitreal Injections versus Laser Photocoagulation in Patients with Diabetic Macular Edema

Abstract

Objective: Diabetic macular edema (DME) is a swelling of the retina resulting from leakage of fluid from blood vessels within the macula (the centre of the retina), it involves retinal thickening and formation of hard exudates that occurs secondary to diabetic retinopathy. The aim of the study was to evaluate the safety and efficacy of ranibizumab versus laser therapy in DME patients. Methods: A randomized controlled open labeled clinical trial with 4 months duration was performed. 40 Patients with DME were randomly allocated to receive either ranibizumab 0.5mg intravitreal injection monthly for three months or laser photocoagulation at baseline and were evaluated at baseline and one month after completing their treatments. Clinical assessment was done by measuring best corrected visual acuity (BCVA), central retinal thickness (CRT), and monitoring of the adverse events. Results: Ranibizumab was superior to laser (P=0.0001) in improving BCVA letter score, mean change from baseline to the end of the study was (+8.75 vs +2.75), with significant increase in VA for both ranibizumab (P < 0.0001) and laser (P = 0.005). The mean CRT was significantly reduced from baseline with ranibizumab (-126.4μm) versus laser (-67.85 μm) both with significant change (P<0.0001). Ranibizumab was better in reducing CRT (P=0.0003). No endophthalmitis and no clinically significant increased intraocular pressure (IOP) for both ranibizumab and laser arms. One case of cataract was reported in laser arm. Other adverse events include eye pain, conjunctival hemorrhage (in both arms), increased lacrimation, foreign body sensation and eye floaters (in ranibizumab arm) and eye pruritus (in the laser arm). There were no systemic adverse events and no deaths reported. Conclusion: Ranibizumab provided significantly superior BCVA and CRT improvement over laser therapy. It had a good safety outcome similar to the established safety profile of ranibizumab. It was well tolerated in DME.