Show simple item record

dc.contributor.authorPuri, P
dc.date.accessioned2016-08-17T10:05:43Z
dc.date.available2016-08-17T10:05:43Z
dc.date.issued2016-05
dc.identifier.citationAm J Ophthalmol. 2016 May 7. pii: S0002-9394(16)30195-7. doi: 10.1016/j.ajo.2016.04.020. [Epub ahead of print]language
dc.identifier.urihttp://hdl.handle.net/20.500.12904/913
dc.description.abstractPURPOSE: 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.language
dc.language.isoenlanguage
dc.subjectRanibizumablanguage
dc.subjectDexamethasonelanguage
dc.subjectRetinalanguage
dc.subjectRetinal Vein Occlusionlanguage
dc.subjectIntravitreal Injectionlanguage
dc.titleClinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study.language
dc.typeArticlelanguage
refterms.dateFOA2021-06-03T10:26:32Z


Files in this item

Thumbnail
Name:
ORDA105.pdf
Size:
458.6Kb
Format:
PDF

This item appears in the following Collection(s)

Show simple item record