March 2012
Volume 53, Issue 14
Free
ARVO Annual Meeting Abstract  |   March 2012
HARBOR Study: One-Year Results of Efficacy and Safety of 2.0 mg versus 0.5 mg Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Author Affiliations & Notes
  • Ivan J. Suner
    Retina Associates of Florida, Tampa, Florida
  • Linda Yau
    Genentech, Inc, South San Francisco, California
  • Phil Lai
    Genentech, Inc, South San Francisco, California
  • Footnotes
    Commercial Relationships  Ivan J. Suner, Genentech (F, R), Genentech, Pfizer, Eyetech (C); Linda Yau, Genentech (E); Phil Lai, Genentech (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 3677. doi:
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    • Get Citation

      Ivan J. Suner, Linda Yau, Phil Lai; HARBOR Study: One-Year Results of Efficacy and Safety of 2.0 mg versus 0.5 mg Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2012;53(14):3677.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : Evaluate efficacy and safety of 2.0 mg versus 0.5 mg ranibizumab in patients with subfoveal neovascularization secondary to age-related macular degeneration (wet AMD).

Methods: : Patients ≥50 years of age with subfoveal wet AMD (n=1097) were randomized to receive 2.0 mg or 0.5 mg ranibizumab intravitreal injections dosed monthly or on an as-needed (PRN) basis after three loading doses. 12-month primary endpoint analyses were performed using last observation carried forward to impute for missing data.

Results: : At Month 12, mean change from baseline in best-corrected visual acuity (BCVA) for the four treatment groups (mean number of ranibizumab injections) was: 0.5 monthly, +10.1 letters (11.3 injections); 2.0 monthly, +9.2 letters (11.2 injections); 0.5 PRN, +8.2 letters (7.7 injections); 2.0 mg PRN, +8.6 letters (6.9 injections). The proportion of patients who lost <15 letters from baseline at Month 12 was 97.8%, 93.4%, 94.5%, and 94.9%, respectively. Mean change from baseline in central foveal thickness was -172.0 μm, -163.3 μm, -161.2 μm, and -172.4 μm, respectively. The incidence of ocular and nonocular adverse events (AEs) and serious AEs were consistent with previous ranibizumab trials in AMD and were comparable between groups.

Conclusions: : The one-year results of the HARBOR Study demonstrated excellent and clinically meaningful improvement in visual acuity and anatomic outcomes across all four treatment groups. Through Month 12, superiority of ranibizumab 2.0 mg monthly over ranibizumab 0.5 mg monthly was not demonstrated by the mean change from baseline in BCVA, and the PRN groups did not met the prespecified noninferiority criteria (margin of 4 letters) to ranibizumab 0.5 mg monthly. The proportion of patients who lost <15 letters at Month 12 from baseline were similar in the 0.5 mg PRN and monthly groups. No new safety signals were observed.

Clinical Trial: : http://www.clinicaltrials.gov NCT00891735

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 
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