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Chelsea Fechter, Dennis M Marcus, Harinderjit Singh, Drew Chamberlain; High-Dose Ranibizumab for Non-Asian Neovascular Polypoidal Choroidal Vasculopathy. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5385.
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To determine safety, tolerability and efficacy of intravitreal high-dose ranibizumab in the treatment of active neovascular polypoidal vasculopathy (PCV). Limited data is available regarding the use of higher doses of ranibizumab for treatment of PCV, particularly in eyes of non-Asian patients.
In this Phase I/II, single-center, randomized, controlled, double-masked study, predominantly non-Asian, previously treated or treatment-naïve, male and female patients >35 years were randomized to receive high-dose (1.0/0.1 mL or 2.0 mg/0.05 mL; n=15) or standard-dose (0.5 mg/0.05 mL; n=5) ranibizumab in three monthly loading doses followed by 9 months of criteria-based, as-needed re-treatment. The primary outcome was incidence and severity of ocular and systemic adverse events over the course of 12 months. Secondary outcomes included visual acuity end points measured by BCVA (ETDRS letters at a distance of 4 meters) and anatomic end points measured by OCT, fluorescein and ICG angiography, and fundus photographs. A 1-tailed, independent t-test was performed to compare secondary outcomes with the high-dose and standard-dose groups’ baseline values.
Twenty patients (aged 35-76 years; 8 African-American, 11 Caucasian, 1 Asian) were enrolled. At baseline, in the high- and standard-dose group respectively, mean best-corrected visual acuity (BCVA) was 63.5 ETDRS letters (Snellen equivalent ~20/50) and 82.8 ETDRS letters (Snellen equivalent ~20/25). The mean baseline choroid foveal thickness (CFT) was 253.7 µm and 301.6 µm, respectively. High- and standard-dose ranibizumab were generally well tolerated without evidence of ocular or systemic severe adverse events, including arterial thromboembolic events. At month 12, in the high-dose and standard-dose group respectively, the mean overall change from baseline in BCVA was +6.7 letters vs -5.0 letters (P=0.0082) and the change in CFT was -49.7 µm vs -94.4 µm (P=0.19). CFT findings may indicate a more favorable anatomic result with high dose ranibizumab for eyes with more active exudation at baseline. Additionally, there was a trend towards greater average gains in BCVA (ETDRS letters) at months 3, 6, 9, and 12 in patients treated with high-dose ranibizumab (1.0 or 2.0 mg) compared with those who received standard-dose (0.5 mg).
High-dose ranibizumab monotherapy may provide safe and efficacious treatment for non-Asian patients with exudative PCV.
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