PMID- 28251811 OWN - NLM STAT- MEDLINE DCOM- 20180209 LR - 20220408 IS - 1755-3768 (Electronic) IS - 1755-375X (Linking) VI - 96 IP - 1 DP - 2018 Feb TI - Head-to-head comparison of ranibizumab PRN versus single-dose dexamethasone for branch retinal vein occlusion (COMRADE-B). PG - e10-e18 LID - 10.1111/aos.13381 [doi] AB - 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. CI - (c) 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd. FAU - Hattenbach, Lars-Olof AU - Hattenbach LO AD - Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany. FAU - Feltgen, Nicolas AU - Feltgen N AD - Department of Ophthalmology, Georg-August-University Gottingen, Gottingen, Germany. FAU - Bertelmann, Thomas AU - Bertelmann T AD - Department of Ophthalmology, Georg-August-University Gottingen, Gottingen, Germany. AD - Novartis Pharma GmbH, Nuremberg, Germany. FAU - Schmitz-Valckenberg, Steffen AU - Schmitz-Valckenberg S AD - Department of Ophthalmology, GRADE Reading Center, University of Bonn, Bonn, Germany. 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 - 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. AD - Department of Ophthalmology, Charite - Universitatsmedizin, Berlin, Germany. FAU - Taylor, Simon R AU - Taylor SR AD - Department of Ophthalmology, University of Surrey, Guildford, UK. FAU - Wolf, Armin AU - Wolf A AD - Department of Ophthalmology, Ludwig-Maximilians University, Munich, 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 - Pielen, Amelie AU - Pielen A AD - Department of Ophthalmology, Medizinische Hochschule Hannover, Hannover, Germany. FAU - Hoerauf, Hans AU - Hoerauf H AD - Department of Ophthalmology, Georg-August-University Gottingen, Gottingen, Germany. CN - COMRADE-B Study Group LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170302 PL - England TA - Acta Ophthalmol JT - Acta ophthalmologica JID - 101468102 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Glucocorticoids) RN - 0 (Vascular Endothelial Growth Factor A) RN - 7S5I7G3JQL (Dexamethasone) RN - ZL1R02VT79 (Ranibizumab) SB - IM MH - Aged MH - Angiogenesis Inhibitors/administration & dosage MH - Dexamethasone/*administration & dosage MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Fovea Centralis/pathology MH - Glucocorticoids/administration & dosage MH - Humans MH - Intravitreal Injections MH - Male MH - Middle Aged MH - Ranibizumab/*administration & dosage MH - Retinal Vein Occlusion/diagnosis/*drug therapy/physiopathology MH - Retrospective Studies MH - Time Factors MH - Tomography, Optical Coherence MH - Treatment Outcome MH - Vascular Endothelial Growth Factor A/antagonists & inhibitors MH - *Visual Acuity OTO - NOTNLM OT - PRN OT - branch retinal vein occlusion OT - dexamethasone OT - ranibizumab EDAT- 2017/03/03 06:00 MHDA- 2018/02/10 06:00 CRDT- 2017/03/03 06:00 PHST- 2016/06/15 00:00 [received] PHST- 2016/12/08 00:00 [accepted] PHST- 2017/03/03 06:00 [pubmed] PHST- 2018/02/10 06:00 [medline] PHST- 2017/03/03 06:00 [entrez] AID - 10.1111/aos.13381 [doi] PST - ppublish SO - Acta Ophthalmol. 2018 Feb;96(1):e10-e18. doi: 10.1111/aos.13381. Epub 2017 Mar 2.