PMID- 27163237 OWN - NLM STAT- MEDLINE DCOM- 20170504 LR - 20220408 IS - 1879-1891 (Electronic) IS - 0002-9394 (Linking) VI - 169 DP - 2016 Sep TI - Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study. PG - 258-267 LID - S0002-9394(16)30195-7 [pii] LID - 10.1016/j.ajo.2016.04.020 [doi] AB - 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. CI - Copyright (c) 2016 Elsevier Inc. All rights reserved. FAU - Hoerauf, Hans AU - Hoerauf H AD - Department of Ophthalmology, Georg-August-University Gottingen, Gottingen, Germany. Electronic address: hanshoerauf@yahoo.com. FAU - Feltgen, Nicolas AU - Feltgen N AD - Department of Ophthalmology, Georg-August-University Gottingen, Gottingen, Germany. FAU - Weiss, Claudia AU - Weiss C AD - Novartis Pharma GmbH, Nuremberg, Germany. FAU - Paulus, Eva-Maria AU - Paulus EM AD - Novartis Pharma GmbH, Nuremberg, Germany. FAU - Schmitz-Valckenberg, Steffen AU - Schmitz-Valckenberg S AD - GRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany. FAU - Pielen, Amelie AU - Pielen A AD - University Eye Hospital, Universitatsklinikum Freiburg, Freiburg, Germany. FAU - Puri, Pankaj AU - Puri P AD - Department of Ophthalmology, Royal Derby Hospital, Derby, United Kingdom. FAU - Berk, Husnu AU - Berk H AD - Department of Ophthalmology, St. Elisabeth-Hospital, Koeln-Hohenlind, Germany. FAU - Eter, Nicole AU - Eter N AD - Department of Ophthalmology, University of Munster Medical Center, Munster, Germany. FAU - Wiedemann, Peter AU - Wiedemann P AD - Department of Ophthalmology, University of Leipzig, Leipzig, Germany. FAU - Lang, Gabriele E AU - Lang GE AD - Department of Ophthalmology, University of Ulm, Ulm, Germany. FAU - Rehak, Matus AU - Rehak M AD - Department of Ophthalmology, University of Leipzig, Leipzig, Germany; Department of Ophthalmology, Charite - Universitatsmedizin, Berlin, Germany. FAU - Wolf, Armin AU - Wolf A AD - Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany. FAU - Bertelmann, Thomas AU - Bertelmann T AD - Novartis Pharma GmbH, Nuremberg, Germany; Department of Ophthalmology, Philipps-University Marburg, Marburg, Germany. FAU - Hattenbach, Lars-Olof AU - Hattenbach LO AD - Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany. CN - COMRADE-C Study Group LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20160507 PL - United States TA - Am J Ophthalmol JT - American journal of ophthalmology JID - 0370500 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Drug Implants) RN - 0 (Glucocorticoids) RN - 0 (VEGFA protein, human) RN - 0 (Vascular Endothelial Growth Factor A) RN - 7S5I7G3JQL (Dexamethasone) RN - ZL1R02VT79 (Ranibizumab) SB - IM CIN - Am J Ophthalmol. 2016 Sep;169:292-293. PMID: 27401725 CIN - Am J Ophthalmol. 2016 Sep;169:291-292. PMID: 27401726 MH - Aged MH - Angiogenesis Inhibitors/adverse effects/*therapeutic use MH - Dexamethasone/adverse effects/*therapeutic use MH - Double-Blind Method MH - Drug Implants MH - Europe MH - Female MH - Glucocorticoids/adverse effects/*therapeutic use MH - Health Status MH - Humans MH - Intravitreal Injections MH - Macular Edema/*drug therapy/physiopathology MH - Male MH - Middle Aged MH - Quality of Life MH - Ranibizumab/adverse effects/*therapeutic use MH - Retinal Vein Occlusion/*drug therapy/physiopathology MH - Tomography, Optical Coherence MH - Vascular Endothelial Growth Factor A/antagonists & inhibitors MH - Visual Acuity/physiology EDAT- 2016/05/11 06:00 MHDA- 2017/05/05 06:00 CRDT- 2016/05/11 06:00 PHST- 2016/01/27 00:00 [received] PHST- 2016/04/26 00:00 [revised] PHST- 2016/04/27 00:00 [accepted] PHST- 2016/05/11 06:00 [entrez] PHST- 2016/05/11 06:00 [pubmed] PHST- 2017/05/05 06:00 [medline] AID - S0002-9394(16)30195-7 [pii] AID - 10.1016/j.ajo.2016.04.020 [doi] PST - ppublish SO - Am J Ophthalmol. 2016 Sep;169:258-267. doi: 10.1016/j.ajo.2016.04.020. Epub 2016 May 7.