Randomized, Double-Maked, ham-Controlled Trial of Ranibizumab for Neovacular Age-related Macular Degeneration: PIER tudy Year 1 Original Reearch Article

Purpoe To evaluate the efficacy and afety of ranibizumab adminitered monthly for three month and then quarterly in patient with ubfoveal choroidal neovacularization (CNV) econdary to age-related macular degeneration (AMD). Deign Phae IIIb, multicenter, randomized, double-maked, ham injection-controlled trial in patient with predominantly or minimally claic or occult with no claic CNV leion. Method Patient were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or ham (n = 63) treatment group. The primary efficacy endpoint wa mean change from baeline viual acuity (VA) at month 12. Reult Mean change from baeline VA at 12 month were −16.3, −1.6, and −0.2 letter for the ham, 0.3 mg, and 0.5 mg group, repectively (P ≤ .0001, each ranibizumab doe v ham). Ranibizumab arreted CNV growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab group during quarterly doing (e.g., at three month the mean change from baeline VA had been gain of 2.9 and 4.3 letter for the 0.3 mg and 0.5 mg doe, repectively). Reult of ubgroup analye of mean change from baeline VA at 12 month by baeline age, VA, and leion characteritic were conitent with the overall reult. Few eriou ocular or nonocular advere event occurred in any group. Concluion Ranibizumab adminitered monthly for three month and then quarterly provided ignificant VA benefit to patient with AMD-related ubfoveal CNV and wa well tolerated. The incidence of eriou ocular or nonocular advere event wa low.