Ramin Tadayoni1, Sebastian M Waldstein2, Francesco Boscia3, Heinrich Gerding4, Ian Pearce5, Siegfried Priglinger6, Andreas Wenzel7, Elizabeth Barnes7, Margarita Gekkieva7, Stefan Pilz8, Jordi Monés9. 1. Ophthalmology Department, Hôpital Lariboisière, AP-HP, Université Paris 7 - Sorbonne Paris Cité, Paris, France. Electronic address: ramin.tadayoni@aphp.fr. 2. Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. 3. Clinica Oculistica, University of Sassari, Sassari, Italy. 4. Department of Retinology, Klinik Pallas, Olten, Switzerland; Department of Ophthalmology, University of Münster, Münster, Germany. 5. St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom. 6. Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany. 7. Novartis Pharma AG, Basel, Switzerland. 8. Munich Re, Munich, Germany. 9. Institut de la Màcula, Centro Médico Teknon, and Barcelona Macula Foundation, Barcelona, Spain.
Abstract
PURPOSE: To compare the 6-month efficacy and safety profile of an individualized stabilization criteria-driven pro re nata (PRN) regimen of ranibizumab 0.5 mg with or without laser versus laser alone in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN: A 24-month, prospective, open-label, randomized, active-controlled, multicenter, phase IIIb study. PARTICIPANTS: A total of 455 patients. METHODS:Eligible patients were randomized 2:2:1 to receive ranibizumab (n = 183), ranibizumab with laser (n = 180), or laser only (n = 92). Patients treated with ranibizumab with or without laser received a minimum of 3 initial monthly ranibizumab injections until visual acuity (VA) stabilization, and VA-based PRN dosing thereafter. In the ranibizumab with laser and laser-only groups, laser was given at the investigator's discretion at a minimum interval of 4 months and if VA was <79 letters. MAIN OUTCOME MEASURES: Mean change from baseline at month 6 in best-corrected visual acuity (BCVA) (primary end point) and central subfield thickness, and safety over 6 months. Exploratory objectives were to evaluate the influence of baseline BCVA, disease duration, and ischemia on BCVA outcomes at month 6. RESULTS:Baseline mean BCVA was 57.7 letters, and mean BRVO duration was 9.9 months. Ranibizumab with or without laser was superior to laser only in improving mean BCVA from baseline at month 6 (14.8 and 14.8 vs. 6.0 letters; both P < 0.0001; primary end point met). Patients with a shorter BRVO duration at baseline had a higher mean BCVA gain than those with a longer BRVO duration. Patients with a poor baseline VA had a better BCVA gain than those with a higher baseline VA, although final BCVA was lower in those with poor baseline VA. In the ranibizumab with or without laser groups, the presence of some macular ischemia at baseline did not influence mean BCVA gains. There were no new ocular or nonocular safety events. CONCLUSIONS:Ranibizumab with an individualized VA-based regimen, with or without laser, showed statistically significant superior improvement in BCVA compared with laser alone in patients with BRVO. Overall, there were no new safety events other than those reported in previous studies.
RCT Entities:
PURPOSE: To compare the 6-month efficacy and safety profile of an individualized stabilization criteria-driven pro re nata (PRN) regimen of ranibizumab 0.5 mg with or without laser versus laser alone in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN: A 24-month, prospective, open-label, randomized, active-controlled, multicenter, phase IIIb study. PARTICIPANTS: A total of 455 patients. METHODS: Eligible patients were randomized 2:2:1 to receive ranibizumab (n = 183), ranibizumab with laser (n = 180), or laser only (n = 92). Patients treated with ranibizumab with or without laser received a minimum of 3 initial monthly ranibizumab injections until visual acuity (VA) stabilization, and VA-based PRN dosing thereafter. In the ranibizumab with laser and laser-only groups, laser was given at the investigator's discretion at a minimum interval of 4 months and if VA was <79 letters. MAIN OUTCOME MEASURES: Mean change from baseline at month 6 in best-corrected visual acuity (BCVA) (primary end point) and central subfield thickness, and safety over 6 months. Exploratory objectives were to evaluate the influence of baseline BCVA, disease duration, and ischemia on BCVA outcomes at month 6. RESULTS: Baseline mean BCVA was 57.7 letters, and mean BRVO duration was 9.9 months. Ranibizumab with or without laser was superior to laser only in improving mean BCVA from baseline at month 6 (14.8 and 14.8 vs. 6.0 letters; both P < 0.0001; primary end point met). Patients with a shorter BRVO duration at baseline had a higher mean BCVA gain than those with a longer BRVO duration. Patients with a poor baseline VA had a better BCVA gain than those with a higher baseline VA, although final BCVA was lower in those with poor baseline VA. In the ranibizumab with or without laser groups, the presence of some macular ischemia at baseline did not influence mean BCVA gains. There were no new ocular or nonocular safety events. CONCLUSIONS:Ranibizumab with an individualized VA-based regimen, with or without laser, showed statistically significant superior improvement in BCVA compared with laser alone in patients with BRVO. Overall, there were no new safety events other than those reported in previous studies.
Authors: Maria-Magdalena Guichard; Anton R Xavier; Cengiz Türksever; Christian Pruente; Katja Hatz Journal: Ophthalmic Res Date: 2018-03-22 Impact factor: 2.892