Lars-Olof Hattenbach1, Nicolas Feltgen2, Thomas Bertelmann2,3, Steffen Schmitz-Valckenberg4, Hüsnü Berk5, Nicole Eter6, Gabriele E Lang7, Matus Rehak8,9, Simon R Taylor10, Armin Wolf11, Claudia Weiss3, Eva-Maria Paulus3, Amelie Pielen12, Hans Hoerauf2. 1. Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany. 2. Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany. 3. Novartis Pharma GmbH, Nuremberg, Germany. 4. Department of Ophthalmology, GRADE Reading Center, University of Bonn, Bonn, Germany. 5. Department of Ophthalmology, St. Elisabeth-Hospital, Koeln-Hohenlind, Germany. 6. Department of Ophthalmology, University of Münster Medical Center, Münster, Germany. 7. Department of Ophthalmology, University of Ulm, Ulm, Germany. 8. Department of Ophthalmology, University of Leipzig, Leipzig, Germany. 9. Department of Ophthalmology, Charité - Universitätsmedizin, Berlin, Germany. 10. Department of Ophthalmology, University of Surrey, Guildford, UK. 11. Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany. 12. Department of Ophthalmology, Medizinische Hochschule Hannover, Hannover, Germany.
Abstract
PURPOSE: To compare the efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg according to their European labels in macular oedema secondary to branch retinal vein occlusion (BRVO) in a 6-month, phase IIIb, randomized trial. METHODS: Patients received either monthly ranibizumab for 3 months followed by Pro re nata (PRN) treatment (n = 126) or a sustained-release dexamethasone implant followed by PRN sham injections (n = 118). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean changes in BCVA and foveal centre point thickness (FCPT), and adverse events (AEs). RESULTS: There was no difference in BCVA gains between the treatments prior to month 3. Best-corrected visual acuity (BCVA) gain with dexamethasone declined thereafter. From month 3 to month 6, mean BCVA change from baseline was significantly higher with ranibizumab than with dexamethasone [raw means (standard deviation):+16.2 (±11) letters versus +9.3 (±10.1) letters]. At month 6, the difference in BCVA gains from baseline was +17.3 letters in the ranibizumab versus +9.2 letters in the dexamethasone group. Patients in the ranibizumab group received a mean of 2.94 loading injections and 1.74 PRN retreatment injections, while those in the dexamethasone group received a single loading injection. Elevated intraocular pressure (IOP) and AEs were more frequent with dexamethasone than ranibizumab treatment. CONCLUSION:Ranibizumab PRN resulted in greater visual acuity (VA) gains in macular oedema following BRVO compared with single-dose dexamethasone over a 6-month study period, observed from month 3, when administered according to their European label. In clinical practice, retreatment with dexamethasone may be required prior to this point.
RCT Entities:
PURPOSE: To compare the efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg according to their European labels in macular oedema secondary to branch retinal vein occlusion (BRVO) in a 6-month, phase IIIb, randomized trial. METHODS:Patients received either monthly ranibizumab for 3 months followed by Pro re nata (PRN) treatment (n = 126) or a sustained-release dexamethasone implant followed by PRN sham injections (n = 118). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean changes in BCVA and foveal centre point thickness (FCPT), and adverse events (AEs). RESULTS: There was no difference in BCVA gains between the treatments prior to month 3. Best-corrected visual acuity (BCVA) gain with dexamethasone declined thereafter. From month 3 to month 6, mean BCVA change from baseline was significantly higher with ranibizumab than with dexamethasone [raw means (standard deviation):+16.2 (±11) letters versus +9.3 (±10.1) letters]. At month 6, the difference in BCVA gains from baseline was +17.3 letters in the ranibizumab versus +9.2 letters in the dexamethasone group. Patients in the ranibizumab group received a mean of 2.94 loading injections and 1.74 PRN retreatment injections, while those in the dexamethasone group received a single loading injection. Elevated intraocular pressure (IOP) and AEs were more frequent with dexamethasone than ranibizumab treatment. CONCLUSION:Ranibizumab PRN resulted in greater visual acuity (VA) gains in macular oedema following BRVO compared with single-dose dexamethasone over a 6-month study period, observed from month 3, when administered according to their European label. In clinical practice, retreatment with dexamethasone may be required prior to this point.
Authors: Yongseok Mun; ChulHyoung Park; Da Yun Lee; Tong Min Kim; Ki Won Jin; Seok Kim; Yoo-Ri Chung; Kihwang Lee; Ji Hun Song; Young-Jung Roh; Donghyun Jee; Jin-Woo Kwon; Se Joon Woo; Kyu Hyung Park; Rae Woong Park; Sooyoung Yoo; Dong-Jin Chang; Sang Jun Park Journal: Sci Rep Date: 2022-06-17 Impact factor: 4.996
Authors: Ian Pearce; Andreas Clemens; Michael H Brent; Lin Lu; Roberto Gallego-Pinazo; Angelo Maria Minnella; Catherine Creuzot-Garcher; Georg Spital; Taiji Sakamoto; Cornelia Dunger-Baldauf; Ian L McAllister Journal: PLoS One Date: 2020-06-18 Impact factor: 3.240