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M. Singer, P. Wong, P.-W. Wang, L. Scott; HORIZON Extension Trial of Ranibizumab (LUCENTIS®) for Neovascular Age-Related Macular Degeneration (AMD): Two-Year Safety and Efficacy Results. Invest. Ophthalmol. Vis. Sci. 2009;50(13):3093.
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Report 2-yr results of HORIZON, a multicenter extension study assessing long-term safety/efficacy of intravitreal ranibizumab injections in patients with subfoveal choroidal neovascular AMD who had completed 1 of 3 Genentech-sponsored, 2-yr, randomized, controlled trials of monthly intravitreal ranibizumab treatment (MARINA, ANCHOR, or FOCUS).
After completing MARINA, ANCHOR or FOCUS, ranibizumab-treated or ranibizumab-naïve patients were eligible for open-label 0.5 mg ranibizumab therapy at ≥ 30-day intervals (schedule set by investigator) in HORIZON if it was expected they might benefit from continuing/starting ranibizumab. Primary outcome measures were the incidence and severity of ocular and nonocular AEs. Secondary outcome measures were best-corrected visual acuity (VA) assessed every 3 months.
The following are preliminary 2 year results. The final results will be included in the presentation. Results are divided into 3 groups: initial-ranibizumab-treated, initial-control but received ranibizumab, and never received ranibizumab. Of 853 pts in HORIZON, 91% enrolled ≤ 30 days after completing their initial trial (range, 0-370 days). Of 600 initial-ranibizumab-treated pts, 69% received injections (median, 4 injections; range 1-21) during 2 years in HORIZON, and 2-yr VA was available for 384/600 pts (64%). Among these 384 pts, median Snellen VA increased by 3 lines from 20/100 to 20/50 during the initial 2-year trial, then decreased 2 lines from HORIZON baseline to 20/80 at year 2 of HORIZON. Of the 600 initial-ranibizumab-treated pts, during the 2 years, the most common study-eye ocular AEs were macular degeneration (34%), retinal hemorrhage (25%) and conjunctival hemorrhage (21%); while the most common non-ocular AEs nasopharyngitis, hypertension, and bronchitis (6-8%).
The median VA gain seen after 2-year monthly ranibizumab in the initial trials decreased with less frequent ranibizumab dosing in the third and fourth year (2 years in HORIZON). No new safety issues emerged. Two-year outcomes for other groups will also be presented.
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