Prospective Trial Comparing Ranibizumab Monthly to Treat & Extend With & Without Angiography-Guided Laser for DME: TREX-DME 1 Year Outcomes

Abstract

Purpose : To compare monthly dosing to a treat & extend algorithm using 0.3 mg ranibizumab with and without angiography-guided laser photocoagulation for center-involving diabetic macular edema (DME).

Methods : This is a multicenter, prospective, randomized clinical trial of 150 eyes randomized 1:2:2 into three cohorts: Monthly (n=30), TReat & EXtend without macular laser photocoagulation (TREX; n=60), and treat & extend with angiography-GuIded LAser photocoagulation (GILA; n=60). Eyes in the TREX and GILA cohorts underwent 4 monthly injections of ranibizumab followed by a treat & extend algorithm based on disease activity. Those in the GILA cohort also received angiography-guided laser photocoagulation at month 1 and again every 3 months if microaneurysm leakage was present.

Results : Baseline demographics and markers of disease severity including duration of diabetes, insulin usage, body-mass index, severity of diabetic retinopathy, best corrected visual acuity (BCVA), and central retinal thickness (CRT) were well balanced between the three cohorts. 136 eyes (91%) completed the 1 year end-point visit. At 1 year, the BCVA improved 8.6, 9.6, 9.3 letters in the Monthly, TREX and GILA cohorts, respectively (p=0.8). Likewise, CRT by spectral-domain optical coherence tomography improved by 122, 146 and 165 µm, in the Monthly, TREX, GILA cohorts, respectively (p=0.47). The mean number of laser treatments in the GILA cohort at 1 year was 2.8 (range=1-4). Treatment burden, defined as the number of injections through 1 year, was significantly reduced in TREX (10.7) and GILA (10.2) compared to the Monthly cohort (13.1, p<0.001). Furthermore, there was a trend towards statistical significance in the mean maximum interval at month 12 for the TREX and GILA cohorts (8.1 versus 9.1 weeks, respectively; p=0.105). There were no cases of endophthalmitis, and the total incidence of nonfatal myocardial infarctions/cerebrovascular accidents, and deaths from vascular/unknown causes was 3.3%.

Conclusions : In this prospective, randomized trial involving 150 eyes, treat & extend dosing of ranibizumab with and without angiography-guided laser photocoagulation significantly decreased treatment burden while providing similar visual and anatomic outcomes compared to monthly dosing at 1 year.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Figure 1: LOESS regression analysis demonstrates longer treatment interval for the TREX/GILA cohorts.