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

To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. This was a multicenter, randomized, clinical trial. One hundred fifty eyes were randomized into 3 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 0.3mg every 4weeks. TREX and GILA cohort eyes received 4monthly injections of ranibizumab 0.3mg followed by a treat and extend dosing strategy. GILA cohort eyes also received navigated focal laser at month 1 and again every 3months as needed. The primary outcomes included the mean change in best-corrected visual acuity and central retinal thickness and the number of injections from baseline to 2 years. At 2 years, mean best-corrected visual acuity and central retinal thickness improved by 7.5, 9.6, and 9.0 letters (P= .75) and 139, 140, and 175μm (P= .09), in the monthly, TREX, and GILA cohorts, respectively. The mean number of injections was significantly reduced in both the TREX (18.9) and GILA (17.5) cohorts compared with the monthly cohort (24.7, P < .001). Between the TREX and GILA cohorts, there was no significant difference in the mean treatment interval, mean maximal treatment interval, or percentage of eyes extended to 12weeks. The total 2-year incidence of Anti-Platelet Trialists' Collaboration events was 6.7%. The treat and 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.