Hans Hoerauf1, Nicolas Feltgen2, Claudia Weiss3, Eva-Maria Paulus3, Steffen Schmitz-Valckenberg4, Amelie Pielen5, Pankaj Puri6, Hüsnü Berk7, Nicole Eter8, Peter Wiedemann9, Gabriele E Lang10, Matus Rehak11, Armin Wolf12, Thomas Bertelmann13, Lars-Olof Hattenbach14. 1. Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany. Electronic address: hanshoerauf@yahoo.com. 2. Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany. 3. Novartis Pharma GmbH, Nuremberg, Germany. 4. GRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany. 5. University Eye Hospital, Universitätsklinikum Freiburg, Freiburg, Germany. 6. Department of Ophthalmology, Royal Derby Hospital, Derby, United Kingdom. 7. Department of Ophthalmology, St. Elisabeth-Hospital, Koeln-Hohenlind, Germany. 8. Department of Ophthalmology, University of Münster Medical Center, Münster, Germany. 9. Department of Ophthalmology, University of Leipzig, Leipzig, Germany. 10. Department of Ophthalmology, University of Ulm, Ulm, Germany. 11. Department of Ophthalmology, University of Leipzig, Leipzig, Germany; Department of Ophthalmology, Charité - Universitätsmedizin, Berlin, Germany. 12. Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany. 13. Novartis Pharma GmbH, Nuremberg, Germany; Department of Ophthalmology, Philipps-University Marburg, Marburg, Germany. 14. Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany.
Abstract
PURPOSE: To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO). DESIGN: Phase IIIb, multicenter, double-masked, randomized clinical trial. METHODS: Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs). RESULTS:Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%). CONCLUSIONS: Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported.
RCT Entities:
PURPOSE: To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO). DESIGN: Phase IIIb, multicenter, double-masked, randomized clinical trial. METHODS:Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs). RESULTS: Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%). CONCLUSIONS: Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasonepatients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported.
Authors: Ingrid U Scott; Paul C VanVeldhuisen; Michael S Ip; Barbara A Blodi; Neal L Oden; Maria Figueroa; Pravin U Dugel Journal: Ophthalmology Date: 2016-11-15 Impact factor: 12.079
Authors: Philip Hykin; A Toby Prevost; Sobha Sivaprasad; Joana C Vasconcelos; Caroline Murphy; Joanna Kelly; Jayashree Ramu; Abualbishr Alshreef; Laura Flight; Rebekah Pennington; Barry Hounsome; Ellen Lever; Andrew Metry; Edith Poku; Yit Yang; Simon P Harding; Andrew Lotery; Usha Chakravarthy; John Brazier Journal: Health Technol Assess Date: 2021-06 Impact factor: 4.014
Authors: Meredith M Whiteside; Ellen S Shorter; Mathew S Margolis; Fatima Alvi; Julia B Huecker; Tammy P Than; Mary K Migneco; Jennifer S Harthan; Christina E Morettin; Andrew T E Hartwick; Spencer D Johnson; Chamila D Perera; Mae O Gordon Journal: Optom Vis Sci Date: 2021-05-01 Impact factor: 1.973