Acute intraocular inflammation following intravitreal injection of bevacizumab - a large cluster of cases
Bibliographic record
Abstract
Editors, Intravitreal bevacizumab (Avastin, F. Hoffman – La Roche Ltd.) has frequently been associated with sterile intraocular inflammation. Although the exact cause of this is unknown, it is generally believed to be an immunologic response to the drug or a contaminant. Our group retinal practice in Canada experienced an outbreak of cases in the Fall of 2008. Over the course of 4 weeks, 27 eyes from 23 patients presented with a moderate uveitic response within 2 days of having an intravitreal bevacizumab injection. Interestingly, one patient had bevacizumab injected into both eyes the same day from the same vial, but only developed uveitis in one eye. Four vitreous biopsies and one vitrectomy were performed. All five cultures were sterile. All cases responded well to anti-inflammatory treatment over a few weeks and no permanent visual deficits occurred. There were no cases of recurrence of uveitis with reinjection of bevacizumab. Our outbreak was part of a Canada-wide occurrence (Holland et al. 2009). Most cases were linked to a specific ‘lot’ number of bevacizumab – B3002 B028. The Canadian Ophthalmology Society TASS Task Force along with Health Canada quickly identified the outbreak, determined the strong association with a specific lot number and sent reports worldwide warning against its further use. Laboratory investigation revealed higher levels of two silicone oil residues in the lot number in question when compared to control samples. As well, endotoxin levels were elevated. However, the tested vial still met both ANSI and ISO safety specifications of the medication for its approved intravenous use. Bevacizumab is used off-label in the eye. The acceptable endotoxin levels for intravitreal medications are more stringent. It was not reported whether the elevated endotoxin levels measured still met the specifications for intravitreal use. This lot of bevacizumab was quickly withdrawn from the market by the manufacturer. Our experience has demonstrated the importance of timely adverse event reporting and of co-ordinated national and global surveillance. Likely, many cases of this adverse event were avoided in thanks to the efforts of the Canadian Ophthalmology Society and Health Canada.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".