Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema
Autor: | Beau B. Bruce, Charles C. Wykoff, John F. Payne, W. Lloyd Clark, David M. Brown, David S. Boyer |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
medicine.medical_specialty Visual acuity genetic structures business.industry Diabetic macular edema Treat and extend eye diseases Surgery law.invention 03 medical and health sciences Ophthalmology 030104 developmental biology 0302 clinical medicine Randomized controlled trial law Cohort 030221 ophthalmology & optometry medicine Dosing Ranibizumab medicine.symptom Prospective cohort study business medicine.drug |
Zdroj: | Ophthalmology. 124:74-81 |
ISSN: | 0161-6420 |
Popis: | Purpose 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). Design Multicenter, prospective, randomized clinical trial. Participants 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). Methods 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. Main Outcome Measures 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. Results 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 Conclusions 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. |
Databáze: | OpenAIRE |
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