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Previous Volume 355:1432-1444 October 5, 2006 Number 14 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Steinbrook, R. Editorial by Stone, E. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background We compared ranibizumab — a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A — with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration.

Methods During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months.

Results Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P<0.001 for each comparison). Visual acuity improved by 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 verteporfin group (P<0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P<0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%).

Conclusions Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, 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.

Full Text of this Article

Related Letters:

Ranibizumab for Neovascular Age-Related Macular Degeneration
Liew G., Mitchell P., Gillies M. C., Wong T. Y., Rosenfeld P. J., Brown D. M., Schneider S., the MARINA and ANCHOR Study Groups
Extract | Full Text | PDF  
N Engl J Med 2007; 356:747-750, Feb 15, 2007. Correspondence

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