OBJECTIVE: To assess the benefit of increased follow-up and treatment with ranibizumab between months 24 and 36 in the Ranibizumabfor Edema of the Macula in Diabetes (READ-2) Study. DESIGN: Prospective, interventional, multicenter follow-up of a randomized clinical trial. METHODS:Patients who agreed to participate between months 24 and 36 (ranibizumab, 28 patients; laser, 22; andranibizumab + laser, 24) returned monthly and received ranibizumab, 0.5 mg, if foveal thickness (FTH, center subfield thickness) was 250 μm or greater. Main outcome measures were improvement in best-corrected visual acuity (BCVA) and reduction in FTH between months 24 and 36. RESULTS: Mean improvement from the baseline BCVA in the ranibizumab group was 10.3 letters at month 36 vs 7.2 letters at month 24 (ΔBCVA letters = 3.1, P = .009), and FTH at month 36 was 282 μm vs 352 μm at month 24 (ΔFTH = 70 μm, P = .006). Changes in BCVA and FTH in the laser group (-1.6 letters and -36 μm, respectively) and the ranibizumab + laser group (+2.0 letters and -24 μm) were not statistically significant. The mean number of ranibizumab injections was significantly greater in the ranibizumab group compared with the laser group (5.4 vs 2.3 injections, P = .008) but not compared with the ranibizumab + laser group (3.3, P = .11). CONCLUSIONS: More aggressive treatment with ranibizumab during year 3 resulted in a reduction in mean FTH and improvement in BCVA in the ranibizumab group. More extensive focal/grid laser therapy in the other 2 groups may have reduced the need for more frequent ranibizumab injections to control edema. APPLICATION TO CLINICAL PRACTICE: Long-term visual outcomes for treatment of diabetic macular edema with ranibizumab are excellent, but many patients require frequent injections to optimally control edema and maximize vision. TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT00407381
RCT Entities:
OBJECTIVE: To assess the benefit of increased follow-up and treatment with ranibizumab between months 24 and 36 in the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study. DESIGN: Prospective, interventional, multicenter follow-up of a randomized clinical trial. METHODS:Patients who agreed to participate between months 24 and 36 (ranibizumab, 28 patients; laser, 22; and ranibizumab + laser, 24) returned monthly and received ranibizumab, 0.5 mg, if foveal thickness (FTH, center subfield thickness) was 250 μm or greater. Main outcome measures were improvement in best-corrected visual acuity (BCVA) and reduction in FTH between months 24 and 36. RESULTS: Mean improvement from the baseline BCVA in the ranibizumab group was 10.3 letters at month 36 vs 7.2 letters at month 24 (ΔBCVA letters = 3.1, P = .009), and FTH at month 36 was 282 μm vs 352 μm at month 24 (ΔFTH = 70 μm, P = .006). Changes in BCVA and FTH in the laser group (-1.6 letters and -36 μm, respectively) and the ranibizumab + laser group (+2.0 letters and -24 μm) were not statistically significant. The mean number of ranibizumab injections was significantly greater in the ranibizumab group compared with the laser group (5.4 vs 2.3 injections, P = .008) but not compared with the ranibizumab + laser group (3.3, P = .11). CONCLUSIONS: More aggressive treatment with ranibizumab during year 3 resulted in a reduction in mean FTH and improvement in BCVA in the ranibizumab group. More extensive focal/grid laser therapy in the other 2 groups may have reduced the need for more frequent ranibizumab injections to control edema. APPLICATION TO CLINICAL PRACTICE: Long-term visual outcomes for treatment of diabetic macular edema with ranibizumab are excellent, but many patients require frequent injections to optimally control edema and maximize vision. TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT00407381
Authors: Raquel Lima E Silva; Yogita Kanan; Adam C Mirando; Jayoung Kim; Ron B Shmueli; Valeria E Lorenc; Seth D Fortmann; Jason Sciamanna; Niranjan B Pandey; Jordan J Green; Aleksander S Popel; Peter A Campochiaro Journal: Sci Transl Med Date: 2017-01-18 Impact factor: 17.956
Authors: D S Dhoot; D J Pieramici; M Nasir; A A Castellarin; S Couvillion; R F See; N Steinle; M Bennett; M Rabena; R L Avery Journal: Eye (Lond) Date: 2015-01-30 Impact factor: 3.775
Authors: Jayoung Kim; Raquel Lima E Silva; Ron B Shmueli; Adam C Mirando; Stephany Y Tzeng; Niranjan B Pandey; Elana Ben-Akiva; Aleksander S Popel; Peter A Campochiaro; Jordan J Green Journal: Acta Biomater Date: 2019-07-30 Impact factor: 8.947
Authors: Peter A Campochiaro; Gulnar Hafiz; Tahreem A Mir; Adrienne W Scott; Ingrid Zimmer-Galler; Syed M Shah; Adam S Wenick; Christopher J Brady; Ian Han; Lingmin He; Roomasa Channa; David Poon; Catherine Meyerle; Mary Beth Aronow; Akrit Sodhi; James T Handa; Saleema Kherani; Yong Han; Raafay Sophie; Guohua Wang; Jiang Qian Journal: Am J Ophthalmol Date: 2016-04-27 Impact factor: 5.258