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Nicolas Feltgen, ; Efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg in central retinal vein occlusion: 6-month results of the COMRADE-C study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5804.
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© ARVO (1962-2015); The Authors (2016-present)
The COMRADE-C study aimed to compare the efficacy and safety of ranibizumab 0.5 mg (RBZ) with dexamethasone 0.7 mg intravitreal implant (DEX) in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
In this 6-month (M) phase IIIb multicenter double masked study, patients (N=243) were randomized (1:1) to receive either RBZ (n=124) or, DEX (n=119). Patients in the RBZ arm received monthly injections until stable visual acuity for 3 consecutive months, followed by pro re nata (PRN) re-treatment. Patients in the DEX arm received an implant at baseline, thereafter sham injections according to the RBZ injection scheme (monthly/PRN). Main outcome measures were mean average change in best-corrected visual acuity (BCVA) from baseline to M1-M6 (primary endpoint), mean changes in BCVA, subfoveal retinal thickness (SRT), and intraocular pressure (IOP), ≥15-letter gainers, and safety over 6M.
Of 243 enrolled patients, 185 (76.1%) completed the study. Baseline demographics were well-balanced between both the treatment arms. The mean average change in BCVA was superior with RBZ compared to DEX from baseline to M1-M6 (+14.6 letters vs +4.8 letters; p<0.0001; primary endpoint met). Although visual and morphological changes were comparable up to M2, the mean change in BCVA was significantly higher with RBZ than DEX (+16.9 letters vs −0.7 letters; p<0.0001; Figure 1) and the mean SRT reduction was significantly greater with RBZ vs DEX (426.2 µm vs 236.0 µm; p<0.001) at M6. The mean IOP increase was higher from M1 to M2-3 with DEX, while it remained relatively constant in the RBZ arm (Figure 2). At M6, significantly greater proportion of patients with RBZ had a ≥15-letter gain vs DEX (58.9% vs 18.5%; p<0.0001). Ocular adverse events (AEs) were reported in more DEX recipients than RBZ recipients (86.6% vs 55.6%) and more DEX recipients had an elevated IOP than RBZ recipients (31.9% vs 5.6%). Overall, no new safety findings were reported during the study period.
COMRADE-C demonstrated superiority of RBZ over DEX in patients with macular edema secondary to CRVO over 6M of treatment. Both the treatments were well-tolerated, with higher incidence of ocular AEs and IOP increase observed with DEX compared to RBZ.
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