Ranibizumab versus verteporfin for neovascular age-related macular degeneration.
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].).
Brown
David M
DM
Vitreoretinal Consultants, Methodist Hospital, Houston, TX 77030, USA. dmbmd@houstonretina.com
Kaiser
Peter K
PK
Michels
Mark
M
Soubrane
Gisele
G
Heier
Jeffrey S
JS
Kim
Robert Y
RY
Sy
Judy P
JP
Schneider
Susan
S
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D020256:Choroidal Neovascularization / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007267:Injections; D008268:Macular Degeneration / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011166:Porphyrins / Q000009:adverse effects / Q000627:therapeutic use*; D000069579:Ranibizumab; D000077362:Verteporfin; D014792:Visual Acuity / Q000187:drug effects
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D000069579:Ranibizumab