학술논문
Randomized Trial of Treat and Extend Ranibizumab With and Without Navigated Laser Versus Monthly Dosing for Diabetic Macular Edema: TREX-DME 2-Year Outcomes
Document Type
Periodical
Author
Payne, John F.; Wykoff, Charles C.; Clark, W. Lloyd; Bruce, Beau B.; Boyer, David S.; Brown, David M.; Wells, John A., III; Johnson, David L.; Benz, Matthew; Chen, Eric; Fish, Richard H.; Kim, Rosa Y.; Major, James C., Jr.; O'Malley, Ronan E.; Schefler, Amy C.; Shah, Ankoor R.; Wong, Tien P.; Novack, Roger L.; Chu, Thomas G.; Rahhal, Firas; Tabandeh, Homayoun; Roe, Richard H.; Dayani, Pouya N.; Liao, David; Walsh, Alexander; Esmaili, Daniel D.
Source
American Journal of Ophthalmology. June 2019, Vol. 202, 91
Subject
Language
English
ISSN
0002-9394
Abstract
Purpose To prospectively evaluate a treat and extend algorithm of ranibizumab with and without navigated laser to monthly dosing for center-involving diabetic macular edema. Design This was a multicenter, randomized, clinical trial. Methods 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 0.3 mg every 4 weeks. TREX and GILA cohort eyes received 4 monthly injections of ranibizumab 0.3 mg followed by a treat and extend dosing strategy. GILA cohort eyes also received navigated focal laser at month 1 and again every 3 months 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. Results 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 175 [mu]m (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 12 weeks. The total 2-year incidence of Anti-Platelet Trialists' Collaboration events was 6.7%. Conclusion 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.