Randomized Trial of Treat and Extend Ranibizumab With and Without Navigated Laser Versus Monthly Dosing for Diabetic Macular Edema: TREX-DME 2-Year Outcomes

Abstract Purpose To prospectively evaluate a treat & extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. Design Multicenter, randomized, clinical trial Methods 150 eyes were randomized into three cohorts: Monthly (n=30), TReat and EXtend without laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded LAser photocoagulation (GILA; n=60). Monthly cohort eyes received ranibizumab 0.3 mg every four weeks. TREX and GILA cohort eyes received 4 monthly injections of ranibizumab 0.3 mg followed by a treat & extend dosing strategy. GILA cohort eyes also received navigated focal laser at month 1 and again every 3 months as needed. Main outcomes include the mean change in best corrected visual acuity (BCVA) and central retinal thickness (CRT), and number of injections from baseline to 2 years. Results At 2 years, mean BCVA and CRT improved by 7.5, 9.6, 9.0 letters (p=0.75) and 139, 140, 175 μm (p=0.09), in the Monthly, TREX, GILA cohorts, respectively. The mean number of injections was significantly reduced in both the TREX (18.9) and GILA (17.5) cohorts compared to the Monthly cohort (24.7,p Conclusion The treat & extend algorithm of ranibizumab in the TREX-DME trial resulted in significantly fewer injections and yielded visual and anatomic gains comparable to monthly dosing at 2 years.