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Nicole Eter, ; Efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg in branch retinal vein occlusion: 6-month results of the COMRADE-B study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5806.
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The COMRADE-B study aimed to compare the efficacy and safety of intravitreal ranibizumab 0.5 mg (RBZ) with dexamethasone 0.7 mg implant (DEX) in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO).
In this 6-month phase IIIb multicenter double-masked study, patients (N=244) were randomized (1:1) to receive either RBZ (n=126) or DEX (n=118). 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 RBZ injection scheme (monthly/PRN). Main outcome measures were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6 (primary endpoint), mean changes in BCVA, subfoveal retinal thickness (SRT), and intraocular pressure (IOP), ≥15-letter gainers, and safety over 6-months.
Of 244 enrolled patients, 215 (88.1%) completed the study. Baseline demographics were well-balanced between both the treatment arms. Mean average change in BCVA was superior with RBZ compared to DEX from baseline to month 1 through month 6 (+14.9 letters vs +10.1 letters; p<0.0001; primary endpoint met). At month 6, mean BCVA change was significantly higher with RBZ vs DEX (+17.3 letters vs +9.2 letters; p<0.0001; Figure 1) and mean SRT reduction was significantly greater with RBZ vs DEX (274.6 µm vs 129.5 µm; p<0.001). Mean IOP increase was higher from month 1 to month 2-3 with DEX, while it remained relatively constant in the RBZ arm (Figure 2). At month 6, a significantly greater proportion of patients with RBZ had ≥15-letter gain vs DEX (61.1% vs 37.3%; p=0.0002). Ocular adverse events (AEs) were reported in more DEX recipients than in RBZ recipients (62.7% vs 48.4%) and more DEX recipients had elevated IOP than RBZ recipients (14.4% vs 1.6%). Overall, no new safety findings were reported during the study period.
Within the treatment scheme used, COMRADE-B demonstrated superiority of RBZ over DEX in patients with macular edema secondary to BRVO over 6 months of treatment. Both treatments were well-tolerated, with higher incidence of ocular AEs and IOP increase observed with DEX compared to RBZ.
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