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Karl G. Csaky, Howard Shapiro, Lisa Tuomi; Ranibizumab-induced Reduction In The Total Area Of Predominantly Classic Choroidal Neovascularization In Patients With Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2011;52(14):132.
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To investigate the effect of monthly ranibizumab 0.3 mg and 0.5 mg on the total area of predominantly classic choroidal neovascularization (CNV) in patients with age-related macular degeneration enrolled in the Phase III ANCHOR trial.
Fluorescein angiograms from 280 ranibizumab-treated study eyes were graded at a central reading center. The primary outcome of interest was percent change from baseline to Month 12 for total area of CNV (CNVpct), categorized into 4 classes: (I) reduction of more than 50%, (II) reduction between 50% up to 25%, (III) reduction of 25% to increase of 25%, and (IV) increase of more than 25%.
The mean (range) area of CNV at baseline (disc areas) for the 0.3 mg and 0.5 mg ranibizumab treatment groups were 1.48 (0.11 - 6.80) vs 1.31 (0.05 - 7.50) respectively. At 3 months post-baseline a larger proportion of 0.5 mg patients vs. 0.3 mg patients fell within the CNVpct Class I (Table), though the treatment group difference among all classes was not statistically significant (p=0.11); for a dichotomous comparison of CNVpct Class I vs. all other classes, the treatment group difference trended towards statistical significance. (p=0.076). At 6, 9 and 12 months post-baseline, the percentage distributions comparing 0.3 and 0.5 mg became more similar; the dichotomous comparisons were not statistically significant (p>=0.19). From Month 3 through Month12 the representation of CNVpct Class I increased from 9.1% to 18.2% for 0.3 mg patients and from 16.7% to 22.4% for 0.5 mg patients.
This work demonstrates a trend of more potent CNV reduction with higher doses of ranibizumab in some patients. On-going research is examining correlates of vision with regression rates.
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