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Lars-Olof Hattenbach, ; Efficacy and Safety of 0.5 mg Ranibizumab compared with 0.7 mg dexamethasone intravitreal implant in patients with branch retinal vein occlusion over 6 months: The COMRADE-B study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1830.
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To compare the efficacy and safety over 6 months (M) of 0.5mg Ranibizumab (RAN) administered PRN after 3 monthly injections vs. an implant of 0.7mg dexamethasone (DEX) in patients with BRVO
Patients with visual impairment due to macular edema following BRVO (n=244) were randomized 1:1 to receive 0.5mg RAN intravitreal injections on an as-needed basis (PRN) after 3 loading doses or to receive an intravitreal implant containing 0.7mg DEX every 6M. Mean average best-corrected visual acuity (BCVA) change over 6M (primary endpoint), changes of BCVA and retinal thickness (RT), QoL parameters and occurrence of AEs were evaluated
BCVA at baseline (M0) was 57.2±11.9 (SD) and 58.1±12.0 letters for the RAN and DEX group respectively. The mean average change over 6M (adjusted for M0 BCVA and site effects) was +14.15 [12.51-15.79, 95% CI] letters (RAN) and +9.66 [7.90-11.43] letters (DEX) (p<0.0001). The mean change at M6 was +16.18 [14.04-18.32] (RAN) vs. +8.10 [5.79-10.40] (DEX) letters. RT was reduced from M0 values (545±224 for RAN; 541±233 for DEX) by -275±210 (RAN) and -130±211 (DEX) at M6 (p<0.001). QoL improvement assessed by NEI VFQ-25 from M0 to M6 was significantly higher with RAN than with DEX (7.1±10.1 vs. 2.8±12.4; p=0.003). No significant safety differences were noted except for the more frequent IOP increase seen with DEX (OR CI for ≥10% increase: 0.095-0.382 p<0.0001) BCVA improved steadily from baseline to month 2 in both groups, then was maintained approximately constant under PRN regimen with RAN, but decreased and was maintained at a lower level (ca. -6 letters) with DEX. RT changes followed a similar course (similar improvements to month 2 maintained approximately with RAN but RT increased again and stabilized at intermediate level with DEX). Interestingly, IOP values remained at ca. 15 mmHg with RAN, but rose with DEX to ca. 20 mmHg in month 1 and 2, to return and stabilize at baseline level from M4 on.
Ranibizumab 0.5mg PRN resulted in significantly higher BCVA gains compared to intravitreal dexamethasone implant. Although initial gains were comparable, these were not maintained with dexamethasone after M2
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