Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes

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• 作者：John F. Payne ; MD¹ ; ^{jpayne@palmettoretina.com} ; Charles C. Wykoff ; MD² ; W. Lloyd Clark ; MD¹ ; Beau B. Bruce ; MD ; PhD³ ; David S. Boyer ; MD⁴ ; David M. Brown ; MD² ; for the TREX-DME Study Group^&lowast ;
• 关键词：BCVA ; best-corrected visual acuity ; CRT ; central retinal thickness ; DME ; diabetic macular edema ; ETDRS ; Early Treatment Diabetic Retinopathy Study ; GILA ; treat and extend with angiography-GuIded macular LAser photocoagulation ; LOESS ; locally weighted regression ; SD OCT ; spectral-domain optical coherence tomography ; TREX ; TReat and EXtend without macular laser photocoagulation ; TREX-DME ; Treat and Extend for Diabetic Macular Edema ; VEGF ; vascular endothelial growth factor
• 刊名：Ophthalmology
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：124
• 期：1
• 页码：74-81
• 全文大小：470 K
• 卷排序：124

文摘

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).DesignMulticenter, prospective, randomized clinical trial.ParticipantsA 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).MethodsMonthly 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.Main Outcome MeasuresChange 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.ResultsBaseline 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%.ConclusionsThis 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.