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M. Michels, H. Shapiro, L. Wilson; Ranibizumab (LUCENTIS®) for Neovascular Age-Related Macular Degeneration (AMD): 2-Year Angiographic Results of PIER Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2882. doi: https://doi.org/.
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This phase IIIb study evaluated a less frequent ranibizumab dosing schedule than used in the MARINA and ANCHOR pivotal trials in patients with neovascular AMD. We report lesion anatomic changes in PIER, and explore the relationship to visual acuity (VA) outcome at month 24.
2-year, multicenter, double-masked trial with 184 patients randomized 1:1:1 to 0.3 or 0.5 mg ranibizumab or sham injection (monthly for 3 doses, then quarterly_10 injections total). Sham-injected patients crossed over to 0.5 mg ranibizumab in year 2. The primary endpoint was mean change from baseline VA at year 1. Eligibility was determined by the investigator. The U. of Wisconsin Fundus Photograph Reading Center retrospectively reviewed the images. Fundus photography and fluorescein angiography were done at baseline and months 3, 5, 8, 12, and 24.
The ranibizumab groups had significantly less mean change from baseline than the sham group in total area of choroidal neovascularization (CNV) at month 24 (0.3 mg = 0.29, 0.5 mg = 0.64, sham = 1.90 disc areas [DA]; p<0.003) and at month 12 (0.3 mg = 0.18, 0.5 mg = 0.43, sham = 2.08 DA; p<0.002).Change from baseline in total area of leakage + retinal pigment epithelium staining did not significantly differ among groups at month 24 (0.3 mg =-1.52, 0.5 mg = -1.22, sham = -0.78 DA), but did at month 12 (0.3 mg =-1.41, 0.5 mg = -1.29, sham = +1.40) (p<.0001, each ranibizumab group vs. sham).For each group, the mean change from baseline in total area of lesion at month 12 was smaller, but not significantly, for patients who at month 24 had lost <15 letters from baseline vs. those who lost ≥15 letters (sham = 1.8 and 2.9, 0.3 mg = -0.006 and 0.46, 0.5 mg = 0.19 and 0.35, respectively).
The PIER ranibizumab dosing regimen resulted in smaller changes in areas of CNV vs. sham injection at month 24. Within groups, change from baseline in total area of lesion at 12 months did not significantly differ in patients who lost <15 letters vs. those who lost ≥15 letters at month 24. Further evaluation of the relationship between VA and lesion anatomic changes is being conducted.
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