Ranibizumab for Neovascular Age-Related Macular Degeneration
2006 · paper · Clinical trials
A two-year randomized, sham-controlled trial of monthly ranibizumab eye injections in 716 patients with neovascular age-related macular degeneration. At 12 months, about 94.5% of treated patients lost fewer than 15 letters of vision, versus 62.2% with sham injections.
2 findings
Substance Table 1 sham column (N=238) gives 'Occult with no classic lesion' as '151 (63.4)', so the CNV-type rows add up to 239. Figure 1B/1C gives 150 sham occult patients, and that count adds up to 238.
- p. 5 Table 1 (continued), Type of choroidal neovascularization, Sham Injection column
151 (63.4)
- p. 7 Figure 1B/1C, No. of Observations, Occult with No Classic Lesion
150 151 149
Judge's note: I checked the crop of Table 1 on p5 against the Figure 1B 'No. of Observations' row on p7. Sham column: 151 + 87 + 0 + 1 = 239, but N = 238. The 0.3-mg column adds to 238 and the 0.5-mg column to 240, both matching their N. The figure lists 150 sham occult patients (order sham, 0.3, 0.5: 150, 151, 149, which matches the 0.3 and 0.5 table values). 150/238 = 63.0%, while 151/238 = 63.4%, the same as the 0.3-mg cell. The likely fix is 150 (63.0). I found no erratum among the files.
Second check: another model agreed
Report a problem with this finding
Substance Results text says 'as compared with 11.3% in the sham-injection group (P<0.001)' for 20/40 or better at 12 months, but the Figure 2B 12-month sham bar is labelled 10.9.
- p. 5 Results, paragraph on 20/40 vision
as compared with 11.3% in the sham-injection group (P<0.001)
- p. 8 Figure 2B, 12 Months, sham bar
10.9
Judge's note: The text sentence on p5 points to Fig. 2B and describes the 12-month timepoint. In the Fig. 2B image on p8 the 12-month bars read sham 10.9, 0.3 mg 38.7 and 0.5 mg 40.0. The value 11.3 appears only as the 0.3-mg baseline (Fig. 2B baseline bar, and Table 1: 27 (11.3)). The paper describes only one analysis (LOCF) for these proportions, and I found no alternative population or erratum in the text.
Second check: another model agreed
Report a problem with this finding
2 minor (typos and the like; most checked by the judge only)
Wording Text says 'A small percentage of patients in all three groups tested positive before study treatment', then gives baseline immunoreactivity of '0% in the group receiving 0.5 mg of ranibizumab'.
- p. 11 Results, immunoreactivity paragraph
A small percentage of patients in all three groups tested positive before study treatment
- p. 11 Results, immunoreactivity paragraph
0% in the group receiving 0.5 mg of ranibizumab
Only the authors can say what is right here.
Judge's note: In the p11 images the paragraph says patients were tested at baseline and at months 6, 12 and 24, so baseline is the only pre-treatment test. The listed baseline rates are 0.9% (0.3 mg), 0% (0.5 mg) and 0.5% (sham). One positive patient out of 240 would be 0.4%, so the printed 0% means no positives in that group. That contradicts 'all three groups'. Only the authors can say whether the wording or the 0% is wrong.
Second check: another model agreed
Report a problem with this finding
Typo 'and Table 4 and 5 of the Supplementary Appendix' uses the singular 'Table' for two tables; it should read 'Tables 4 and 5'.
- p. 6 Results, Adverse Events, inflammation paragraph
and Table 4 and 5 of the Supplementary Appen-
Judge's note: The p6 crop shows this wording exactly. It is a cosmetic grammatical slip.
Second check: none (judge only)