Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes.
To compare monthly dosing with a treat and extend algorithm using ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation for center-involving diabetic macular edema (DME).



Multicenter, prospective, randomized clinical trial.



A total of 150 eyes from 116 subjects were randomized into 3 cohorts: Monthly (n = 30), TReat and EXtend without macular laser photocoagulation (TREX; n = 60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n = 60).



Monthly cohort eyes received ranibizumab 0.3 mg every 4 weeks. Eyes in the TREX and GILA cohorts received 4 monthly injections of ranibizumab 0.3 mg followed by a treat and extend algorithm based on disease activity. Eyes in the GILA cohort also received angiography-guided macular laser photocoagulation at month 1 and again every 3 months for microaneurysm leakage.



Change in mean best-corrected visual acuity (BCVA), mean central retinal thickness (CRT), number of injections from baseline to 1 year, and percentage gaining/losing 2 and 3 lines of vision.



Baseline demographics were well balanced among the cohorts. A total of 137 eyes (91%) completed the 1-year end point visit. At 1 year, the mean BCVA improved by 8.6, 9.6, and 9.5 letters in the Monthly, TREX, and GILA cohorts, respectively (P = 0.8). There was no significant difference between the cohorts in the percentage gaining/losing 2 and 3 lines of vision. The CRT improved by 123 μm, 146 μm, and 166 μm in the Monthly, TREX, and GILA cohorts, respectively (P = 0.47). The mean number of macular laser treatments in the GILA cohort at 1 year was 2.9 (range, 1-4). The number of injections was significantly reduced in both the TREX (10.7) and GILA (10.1) cohorts compared with the Monthly cohort (13.1, P < 0.001). There were no cases of endophthalmitis, and the total incidence of Anti-Platelet Trialists' Collaboration events was 4.7%.



This prospective, randomized trial found that treat and extend dosing of ranibizumab 0.3 mg with and without angiography-guided macular laser photocoagulation significantly decreased the number of injections given while providing similar visual and anatomic outcomes compared with monthly dosing at 1 year. Adding angiography-guided laser photocoagulation to this dosing algorithm did not significantly improve outcomes at 1 year.
Palmetto Retina Center, West Columbia, South Carolina. Electronic address: jpayne@palmettoretina.com.
John F
JF
Payne
Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.
Charles C
CC
Wykoff
Palmetto Retina Center, West Columbia, South Carolina.
W Lloyd
WL
Clark
Emory University, Atlanta, Georgia.
Beau B
BB
Bruce
Retina-Vitreous Associates Medical Group, Los Angeles, California.
David S
DS
Boyer
Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.
David M
DM
Brown
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003930:Diabetic Retinopathy / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation / Q000379:methods*; D008269:Macular Edema / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069579:Ranibizumab / Q000627:therapeutic use*; D012160:Retina / Q000473:pathology; D014792:Visual Acuity
D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab