April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
HORIZON Extension Trial of Ranibizumab (LUCENTIS®) for Neovascular Age-Related Macular Degeneration (AMD): Two-Year Safety and Efficacy Results
Author Affiliations & Notes
  • M. Singer
    Medical Center Ophthalmology Associates, San Antonio, Texas
  • P. Wong
    Genentech, Inc., South San Francisco, California
  • P.-W. Wang
    Genentech, Inc., South San Francisco, California
  • L. Scott
    Genentech, Inc., South San Francisco, California
  • Footnotes
    Commercial Relationships  M. Singer, Genentech, Inc., F; P. Wong, Genentech, Inc., E; P.-W. Wang, Genentech, Inc., E; L. Scott, Genentech, Inc., E.
  • Footnotes
    Support  Genentech, Inc.
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 3093. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : 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).

Methods: : 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.

Results: : 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%).

Conclusions: : 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.

Clinical Trial: : www.clinicaltrials.gov NCT00379795

Keywords: age-related macular degeneration • visual acuity 

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