September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Safety and efficacy of ranibizumab 0.5 mg vs dexamethasone 0.7 mg intravitreal implant in patients with branch or central retinal vein occlusion: long-term results of the COMRADE-Extension study
Author Affiliations & Notes
  • Nicolas Feltgen
    Ophthalmology, University Hospital, Goettingen, Germany
  • Thomas Bertelmann
    Clinical Research Retina, Novartis Pharma GmbH, Nuernberg, Germany
  • Footnotes
    Commercial Relationships   Nicolas Feltgen, Allergan (F), Bayer Healthcare (F), Novartis Pharma GmbH (F); Thomas Bertelmann, 90429 (E)
  • Footnotes
    Support  NONE
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Nicolas Feltgen, Thomas Bertelmann; Safety and efficacy of ranibizumab 0.5 mg vs dexamethasone 0.7 mg intravitreal implant in patients with branch or central retinal vein occlusion: long-term results of the COMRADE-Extension study. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : The aim of the COMRADE-Extension study was to evaluate and compare the safety and efficacy of ranibizumab 0.5mg (RBZ) vs dexamethasone 0.7mg intravitreal implant (DEX) in patients with macular edema due to branch/central retinal vein occlusion (BRVO/CRVO) over 12 months (M) in a phase IIIb comparative head-to-head study.

Methods : An open-label, multicenter, 6M extension study that included adult patients (N=175) with macular edema secondary to BRVO (n=92) or CRVO (n=83). After M6, RBZ (n=113) and DEX (n=62) treatments were continued on a pro re nata (PRN) treatment strategy. The primary endpoint was the comparison of safety (treatment emergent adverse events [TEAEs]) in patients treated with RBZ vs DEX over additional 6M. Secondary endpoints included TEAEs with a rise in intraocular pressure (IOP) ≥21 mmHg, mean changes in best-corrected VA (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) and foveal center point thickness (FCPT) from baseline (BSL) to M6/M12.

Results : Of the 175 enrolled patients, 161 (92.0%) completed the extension study. The patient demographic and BSL characteristics were comparable between the RBZ and DEX groups. Cataract development or worsening (RBZ/DEX) was seen in 0 (0.0%)/3 (7.5%) in BRVO and 2 (3.3%)/1 (4.5%) in CRVO patients[N1] . An IOP ≥21 mmHg (RBZ/DEX) was seen in 3 (5.8%)/10 (25.0%) in BRVO and 3 (4.9%)/4 (18.2%) in CRVO patients. The mean changes in BCVA (ETDRS letters) (RBZ/DEX) from BSL–M6 was 19.8/11.7 (p<0.001) and from BSL–M12 was 20.0/12.3 (p=0.001) in BRVO patients (Fig 1). The mean change in BCVA (ETDRS letters) (RBZ/DEX) from BSL–M6 was 18.2/9.6 (p=0.015) and from BSL–M12 was 18.9/11.9 (p=0.069) in CRVO patients (Fig 2). The mean changes in FCPT (µm) (RBZ/DEX) from BSL–M6 was −315.3/−169.4 and from BSL–M12 was −341.8/−252.6 in BRVO patients. The mean change in FCPT (µm) (RBZ/DEX) from BSL–M6 was −427.9/−356.5 and from BSL–M12 was −439.4/−432.3 in CRVO patients.

Conclusions : The superior effect of RBZ over DEX on BCVA gain was maintained up to M12. The mean changes in FCPT were stable at a lower level with RBZ than DEX. The proportion of patients with an episode of elevated IOP was considerably higher with DEX than RBZ. No differences could be found in cataract development.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

 

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