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Head-to-head comparison of ranibizumab PRN versus single-dose dexamethasone for branch retinal vein occlusion (COMRADE-B)

Hattenbach, L-O, Feltgen, N, Bertelmann, T, Schmitz-Valckenberg, S, Berk, H, Eter, N, Lang, GE, Rehak, M, Taylor, Simon, Wolf, A , Weiss, C, Paulus, E-M, Pielen, A and Hoerauf, H (2017) Head-to-head comparison of ranibizumab PRN versus single-dose dexamethasone for branch retinal vein occlusion (COMRADE-B) Acta Ophthalmologica.

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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 eithermonthly ranibizumabfor 3 months followed byPro re nata (PRN) treatment (n = 126) or a sustained-release dexamethasone implant followedbyPRNshaminjections (n = 118).Mainoutcomesweremeanaveragechange in best-corrected visual acuity(BCVA)frombaseline tomonth1throughmonth6,mean changes inBCVAand 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].Atmonth 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.

Item Type: Article
Subjects : Biosciences and Medicine
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
NameEmailORCID
Hattenbach, L-OUNSPECIFIEDUNSPECIFIED
Feltgen, NUNSPECIFIEDUNSPECIFIED
Bertelmann, TUNSPECIFIEDUNSPECIFIED
Schmitz-Valckenberg, SUNSPECIFIEDUNSPECIFIED
Berk, HUNSPECIFIEDUNSPECIFIED
Eter, NUNSPECIFIEDUNSPECIFIED
Lang, GEUNSPECIFIEDUNSPECIFIED
Rehak, MUNSPECIFIEDUNSPECIFIED
Taylor, Simons.r.taylor@surrey.ac.ukUNSPECIFIED
Wolf, AUNSPECIFIEDUNSPECIFIED
Weiss, CUNSPECIFIEDUNSPECIFIED
Paulus, E-MUNSPECIFIEDUNSPECIFIED
Pielen, AUNSPECIFIEDUNSPECIFIED
Hoerauf, HUNSPECIFIEDUNSPECIFIED
Date : 2 March 2017
Identification Number : 10.1111/aos.13381
Copyright Disclaimer : Copyright 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
Uncontrolled Keywords : branch retinal vein occlusion – dexamethasone – PRN – ranibizumab
Related URLs :
Depositing User : Symplectic Elements
Date Deposited : 08 Mar 2017 10:00
Last Modified : 31 Oct 2017 19:11
URI: http://epubs.surrey.ac.uk/id/eprint/813710

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