Ranibizumab and Bevacizumab for Neovascular Age-Related Macular Degeneration
2011 · paper · Clinical trials
A randomized trial of 1208 patients comparing ranibizumab and bevacizumab, given monthly or as needed, for neovascular macular degeneration. At one year the two drugs had equivalent effects on vision when given on the same schedule; serious adverse events were more frequent with bevacizumab.
1 finding
Wording Text says venous thrombotic events "occurred infrequently (in approximately 1.0% of patients)", but Table 3 gives 0, 4 (1.4), 2 (0.7) and 1 (0.3), i.e. 7 of 1185 patients (0.6%).
- p. 5 Results, Adverse Events, last sentence of first paragraph
occurred infrequently (in approximately 1.0% of patients), with the highest number (4, or 1.4%)
- p. 17 Table 3, row 'Venous thrombotic event'
0 4 (1.4) 2 (0.7) 1 (0.3)
Only the authors can say what is right here.
Judge's note: Crop C003-a and the upright image of Table 3 (page 17) read as quoted. The overall rate is 7/1185 = 0.59%; by drug it is 5/586 = 0.85% and 2/599 = 0.33%. No overall or per-drug rate reaches 1.0%, and no other population or definition in the text explains the figure. "Approximately" hedges the statement, so this is an overstatement in wording (possibly "<1.0%" was intended); the authors should confirm.
Second check: another model agreed
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3 minor (typos and the like; most checked by the judge only)
Wording Introduction says "In 2005, clinical trials established the efficacy of ranibizumab1,2" but the two cited reports (refs 1 and 2) are both dated "N Engl J Med. 2006".
- p. 1 Introduction, first sentence
In 2005, clinical trials established the efficacy of ranibizumab
- p. 7 References 1 and 2
N Engl J Med. 2006; 355:1419–31.
Judge's note: Crop C001-a shows "In 2005" with superscript citations 1,2. The reference list in the text layer gives both as N Engl J Med 2006;355. The year in the sentence does not match the cited publications. The next sentence ("While awaiting approval...") suggests the authors may mean when the trial results first became known, so either form could be legitimate; a minor consistency point only.
Second check: another model agreed
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Wording Discussion: "Monthly injections of either drug resulted in no increase in the mean lesion area" (Results: "unchanged from baseline in the two groups that received monthly treatment"), but Table 2 gives a mean change of 0.1±1.9 for bevacizumab monthly (0.0±2.1 for ranibizumab monthly).
- p. 7 Discussion, first paragraph on the page
Monthly injections of either drug resulted in no increase in the mean lesion area, whereas there was a small increase with injections given as needed (Table 2)
- p. 5 Results, Secondary Outcomes, second paragraph
The mean lesion size on fluorescein angiography was unchanged from baseline in the two groups that received monthly treatment
- p. 16 Table 2, Area of lesion, row 'Mean change from baseline'
0.0±2.1 0.1±1.9 0.2±2.5 0.5±2.6
Judge's note: The upright image of Table 2 (page 16) shows mean change in lesion area of 0.0, 0.1, 0.2 and 0.5 optic-disk areas. The bevacizumab-monthly group has +0.1, so "no increase" and "unchanged" are literally exact only for ranibizumab monthly, while +0.2 is called a small increase. A +0.1 change with SD 1.9 is negligible and the phrasing is defensible as approximate language, so this is a minor wording point only.
Second check: another model agreed
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Typo Reference 10 prints the document number as "CMP/EWP/482/99" although the same entry names the committee as "Committee for Proprietary Medicinal Products (CPMP)".
- p. 8 Reference 10
CMP/EWP/482/99
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that the true document identifier is CPMP/EWP/482/99. Crop C009-a confirms the page prints "CMP/EWP/482/99" directly after "(CPMP)" in the same entry, so it is not an extraction artefact. The inconsistency within the entry points to a dropped letter, but the correct identifier cannot be checked from the files.
Second check: none (judge only)