Assessment the microbial contamination rate of re-used vials of bevacizumab(Avastin) and the risk of endophthalmitis.
Background: Introduction of anti-VEGF therapy has changed the way of management to the retinal diseases. Pegaptanib (Macugen)was the first to be approved and was followed by other agents, including ranibizumab (Lucentis, Genentech, San Francisco, Calif.), bevacizumab (Avastin, Genentech) and aflibe...
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| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
university of basrah
2025-06-01
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| Series: | Basrah Journal of Surgery |
| Subjects: | |
| Online Access: | https://bjsrg.uobasrah.edu.iq/article_188701.html |
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| Summary: | Background: Introduction of anti-VEGF therapy has changed the way of management to the retinal diseases. Pegaptanib (Macugen)was the first to be approved and was followed by other agents, including ranibizumab (Lucentis, Genentech, San Francisco, Calif.), bevacizumab (Avastin, Genentech) and aflibercept (Eylea, Regeneron, Tarrytown, N.Y.).
Studies have shown the safety and efficacy of these agents in the treatment of wet Age Related Macular Degeneration(ARMD), Retinal Vein Occlusion (RVO)and Diabetic Macular Oedema(DME). These drugs delivered into the vitreous cavity through pars plana injection, and are generally safe with little serious complications.
Aim: To evaluate the rate of microbial contamination and safety aspects of multi puncture vials of bevacizumab (Avastin) and to determine the rate of endophthalmitis .
Patients and Methods: A multi-centric prospective study conducted at the Basrah general teaching hospital and Al-Zubair general hospital, Basrah, Iraq, a total of 28 consecutive vials of bevacizumab {Avastin; F. Hoffmann-LaRoche Ltd. Switzerland} were used. A total 1096 injections were administered to 899 patients between September 2019 and November 2024. After puncture the vial, multidose used for intravitreal injections, residue bevacizumab in the vial was stored in the refrigerator at 2-8 ̊C and reused for up to 4 weeks. From each vial, a dose of 0.05 ml was withdrawn to a sterile 1ml syringe under aseptic technique and sent for bacterial gram staining and culture.
Results: No evidence of microbial contamination was detected in 28 vials as approved by the results of microbial staining and culture. One patient of 899 patients who received intravitreal injections from these vials showed signs of inflammation, otherwise; no evidence of endophthalmits.
Conclusions: This study propose that the content of multipuncture bevacizumab (Avastin) vials remain sterile over a period of 4 weeks without any microbial contamination if perfect aseptic and storage precautions are maintained. Using multidose of bevacizumab vials for intravitreal injection which stored for up to 4 weeks in refrigerator at temperature of 2-8 ̊C is safe.
Keywords: Bevacizumab, Endophthalmitis, Microbial contamination, multi-use vials |
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| ISSN: | 1683-3589 2409-501X |