Ranibizumab versus Verteporfin for Neovascular Age-Related Macular Degeneration
David M. Brown, M.D., Peter K. Kaiser, M.D., Mark Michels, M.D., Gisele Soubrane, M.D., Jeffrey S. Heier, M.D., Robert Y. Kim, M.D., Judy P. Sy, Ph.D., Susan Schneider, M.D., for the ANCHOR Study Group
Background We compared ranibizumab a recombinant, humanized,monoclonal antibody Fab that neutralizes all active forms ofvascular endothelial growth factor A with photodynamictherapy with verteporfin in the treatment of predominantly classicneovascular age-related macular degeneration.
Methods During the first year of this 2-year, multicenter, double-blindstudy, we randomly assigned patients in a 1:1:1 ratio to receivemonthly intravitreal injections of ranibizumab (0.3 mg or 0.5mg) plus sham verteporfin therapy or monthly sham injectionsplus active verteporfin therapy. The primary end point was theproportion of patients losing fewer than 15 letters from baselinevisual acuity at 12 months.
Results Of the 423 patients enrolled, 94.3% of those given 0.3mg of ranibizumab and 96.4% of those given 0.5 mg lost fewerthan 15 letters, as compared with 64.3% of those in the verteporfingroup (P<0.001 for each comparison). Visual acuity improvedby 15 letters or more in 35.7% of the 0.3-mg group and 40.3%of the 0.5-mg group, as compared with 5.6% of the verteporfingroup (P<0.001 for each comparison). Mean visual acuity increasedby 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mggroup, as compared with a decrease of 9.5 letters in the verteporfingroup (P<0.001 for each comparison). Among 140 patients treatedwith 0.5 mg of ranibizumab, presumed endophthalmitis occurredin 2 patients (1.4%) and serious uveitis in 1 (0.7%).
Conclusions Ranibizumab was superior to verteporfin as intravitrealtreatment of predominantly classic neovascular age-related maculardegeneration, with low rates of serious ocular adverse events.Treatment improved visual acuity on average at 1 year. (ClinicalTrials.govnumber, NCT00061594
[ClinicalTrials.gov]
.)
Source Information
From Vitreoretinal Consultants, Methodist Hospital, Houston (D.M.B.); the Cole Eye Institute, Cleveland Clinic Foundation, Cleveland (P.K.K.); Retina Care Specialists, Palm Beach Gardens, FL (M.M.); the Clinique d'Ophtalmologie, University of Paris XII, Créteil, France (G.S.); Ophthalmic Consultants of Boston, Boston (J.S.H.); and Genentech, South San Francisco, CA (R.Y.K., J.P.S., S.S.).
Address reprint requests to Dr. Brown at Vitreoretinal Consultants, 6560 Fannin St., Suite 750, Houston, TX 77030, or at dmbmd{at}houstonretina.com.
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