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D. M. Brown, H. Yue, N. Shams; Ranibizumab (Lucentis) in Neovascular Age-Related Macular Degeneration (AMD): Subgroup Analysis of Year 1 PIER Efficacy Data. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4540.
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The 2 pivotal studies of LUCENTISTM (ranibizumab) for treating subfoveal choroidal neovascularization (CNV) due to AMD used a monthly injection regimen. The PIER study evaluated 2 doses of LUCENTIS (0.3 mg and 0.5 mg) given monthly for 3 months and then quarterly. In the primary efficacy analysis at 1 year, mean changes from baseline visual acuity (VA) were significantly superior to sham treatment (P ≤.0001), but the mean visual acuity gains seen with monthly dosing were not maintained with quarterly dosing. Subgroup analyses was undertaken to provide guidance on follow-up and retreatment decisions.
PIER is a Phase 3b, 2-year, multicenter, randomized, double-masked, sham-controlled study. 184 patients with neovascular AMD were randomized 1:1:1 to 0.3 or 0.5 mg ranibizumab, or sham injection. For subgroup analysis, patients were classified based on baseline characteristics: age (</≥75 years), sex, and, for the study eye, VA score (</≥54 letters), total AMD lesion size (≤/>4 DA), occult CNV at baseline (yes/no), and prior laser photocoagulation (yes/no). Analyses were performed to identify predictors of VA outcome at 1 year. Additional subgroup analyses were performed for the pooled ranibizumab groups vs. sham based on retinal thickness (per optical coherence tomography) and leakage (per fundus angiography) at months 2, 3, and 5.
The effect of ranibizumab was consistent across age, sex, VA score, lesion size, CNV lesion type, and laser photocoagulation history subgroups. Central retinal thickness, after a gap of 3 months, was a predictor of VA outcome at 1 year. Patients with retinal thickness <200 µm maintained their initial improvement but were not more likely than controls to gain ≥15 letters. Patients who had dry lesions during early treatment maintained their initial improvement and were more likely than controls to gain ≥15 letters.
Retinal thickness and active leakage may provide some guidance for ranibizumab treatment decisions. Patients with retinal thickness ≥200 µm or with wet lesions during early treatment may benefit from more frequent injections.
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