John F Payne1, Charles C Wykoff2, W Lloyd Clark3, Beau B Bruce4, David S Boyer5, David M Brown2. 1. Palmetto Retina Center, West Columbia, South Carolina, USA. Electronic address: jpayne@palmettoretina.com. 2. Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas, USA. 3. Palmetto Retina Center, West Columbia, South Carolina, USA. 4. Emory University, Atlanta, Georgia, USA. 5. Retina-Vitreous Associates Medical Group, Los Angeles, California, USA.
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 μm (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.
RCT Entities:
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 μm (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.
Authors: Helena Giannakaki-Zimmermann; Alexandra Behrndt; Laura Hoffmann; Maria-Magdalena Guichard; Cengiz Türksever; Christian Prünte; Katja Hatz Journal: Ophthalmic Res Date: 2021-01-26 Impact factor: 2.892
Authors: S W Quist; L A de Jong; F van Asten; P Knoester; M J Postma; R D Freriks Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-10-13 Impact factor: 3.117