TY - JOUR
T1 - The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab
AU - Post-Injection Endophthalmitis (PIE) Study Group
AU - Storey, Philip P.
AU - Tauqeer, Zujaja
AU - Yonekawa, Yoshihiro
AU - Todorich, Bozho
AU - Wolfe, Jeremy D.
AU - Shah, Sumit P.
AU - Shah, Ankoor R.
AU - Koto, Takashi
AU - Abbey, Ashkan M.
AU - Morizane, Yuki
AU - Sharma, Priya
AU - Wood, Edward H.
AU - Morizane-Hosokawa, Mio
AU - Pendri, Pooja
AU - Pancholy, Maitri
AU - Harkey, Shawn
AU - Jeng-Miller, Karen W.
AU - Obeid, Anthony
AU - Borkar, Durga S.
AU - Chen, Eric
AU - Williams, Patrick
AU - Okada, Annabelle A.
AU - Inoue, Makoto
AU - Shiraga, Fumio
AU - Hirakata, Akito
AU - Shah, Chirag P.
AU - Prenner, Jonathan
AU - Garg, Sunir
N1 - Funding Information:
Funding/Support: Massachusetts Eye and Ear Infirmary: Yonekawa Research Fund, Mass Eye and Ear and Children's Hospital Ophthalmology Foundation. Ophthalmic Consultants of Boston: Center for Eye Research and Education (CERE), Boston, Massachusetts, USA. Financial Disclosures: Yoshi Yonekawa: Personal fees from Regeneron, Allergan, Alcon, and Optos. Jeremy D. Wolfe: Grants and personal fees from Allergan and Genentech, personal fees from Regeneron. Sumit P. Shah: Personal fees from Genentech, Inc and Regeneron Pharmaceuticals, Inc. Takashi Koto: Personal fees from Alcon Pharmaceuticals, Santen, and Novartis. Ashkan M. Abbey: Personal fees from Genentech. Annabelle A. Okada: Personal fees from Bayer Healthcare AG, Bayer Yakuhin Ltd. (Japan), Alcon Pharma KK (Japan), Santen Pharmaceutical Co. Ltd. (Japan), Mitsubishi Tanabe Pharma Corporation, Astellas Japan, AbbVie Japan, Inc., Senju Pharmaceutical Co., Ltd., and Daiichi-Sankyo. Chirag P. Shah: Grants from Regeneron and personal fees from Genentech. Jonathan Prenner: Personal fees for Alcon. Sunir Garg: Personal fees from Bausch and Lomb, Santen Pharmaceutical Co, Topivert, and Deciphera. The following authors have no financial disclosures: Philip P. Storey, Zujaja Tauqeer, Bozho Todorich, Ankoor R. Shah, Yuki Morizane, Priya Sharma, Edward H. Wood, Mio Morizane-Hosokawa, Pooja Pendri, Maitri Pancholy, Shawn Harkey, Karen W. Jeng-Miller, Anthony Obeid, Durga S. Borkar, Eric Chen, Patrick Williams, Makoto Inoue, Fumio Shiraga, and Akito Hirakata. All authors attest that they meet the current ICMJE criteria for authorship.
Funding Information:
Funding/Support: Massachusetts Eye and Ear Infirmary: Yonekawa Research Fund, Mass Eye and Ear and Children's Hospital Ophthalmology Foundation. Ophthalmic Consultants of Boston: Center for Eye Research and Education (CERE), Boston, Massachusetts, USA. Financial Disclosures: Yoshi Yonekawa: Personal fees from Regeneron, Allergan, Alcon, and Optos. Jeremy D. Wolfe: Grants and personal fees from Allergan and Genentech, personal fees from Regeneron. Sumit P. Shah: Personal fees from Genentech, Inc and Regeneron Pharmaceuticals, Inc. Takashi Koto: Personal fees from Alcon Pharmaceuticals, Santen, and Novartis. Ashkan M. Abbey: Personal fees from Genentech. Annabelle A. Okada: Personal fees from Bayer Healthcare AG, Bayer Yakuhin Ltd. (Japan), Alcon Pharma KK (Japan), Santen Pharmaceutical Co. Ltd. (Japan), Mitsubishi Tanabe Pharma Corporation, Astellas Japan, AbbVie Japan, Inc., Senju Pharmaceutical Co., Ltd., and Daiichi-Sankyo. Chirag P. Shah: Grants from Regeneron and personal fees from Genentech. Jonathan Prenner: Personal fees for Alcon. Sunir Garg: Personal fees from Bausch and Lomb, Santen Pharmaceutical Co, Topivert, and Deciphera. The following authors have no financial disclosures: Philip P. Storey, Zujaja Tauqeer, Bozho Todorich, Ankoor R. Shah, Yuki Morizane, Priya Sharma, Edward H. Wood, Mio Morizane-Hosokawa, Pooja Pendri, Maitri Pancholy, Shawn Harkey, Karen W. Jeng-Miller, Anthony Obeid, Durga S. Borkar, Eric Chen, Patrick Williams, Makoto Inoue, Fumio Shiraga, and Akito Hirakata. All authors attest that they meet the current ICMJE criteria for authorship.
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2019/3
Y1 - 2019/3
N2 - Purpose: To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation. Design: Multicenter retrospective cohort study. Methods: All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum. Results: A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026%; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013%; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015%; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026%; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95% confidence interval 0.31-1.12; P =.10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95% confidence interval 0.045-0.82; P =.025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P =.0062). Oral-associated flora was found in 27.3% (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group. Conclusion: In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.
AB - Purpose: To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation. Design: Multicenter retrospective cohort study. Methods: All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum. Results: A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026%; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013%; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015%; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026%; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95% confidence interval 0.31-1.12; P =.10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95% confidence interval 0.045-0.82; P =.025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P =.0062). Oral-associated flora was found in 27.3% (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group. Conclusion: In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.
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U2 - 10.1016/j.ajo.2018.11.023
DO - 10.1016/j.ajo.2018.11.023
M3 - Article
C2 - 30552891
AN - SCOPUS:85059606896
SN - 0002-9394
VL - 199
SP - 200
EP - 208
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -