Association of Acute Endophthalmitis With Intravitreal Injections of Corticosteroids or Anti–Vascular Growth Factor Agents in a Nationwide Study in France
Abstract:The number of patients affected by retinal diseases treated with intravitreal injections (IVTs) has resulted in a rapidly growing number of procedures. One of the worst complications after these injections is endophthalmitis.OBJECTIVE To evaluate the incidence of acute endophthalmitis after IVTs of corticosteroids or anti-vascular endothelial growth factor (anti-VEGF) agents. DESIGN, SETTING, AND PARTICIPANTS This population-based cohort study included patients undergoing IVTs from January 1, 2012, through Dec… Show more
“…Two large population-based studies have been published in recent years analyzing the endophthalmitis rate after intravitreal injection. 41,42 Baudin et al evaluated the incidence of acute endophthalmitis after intravitreal injection of corticosteroids or anti-VEGF agents in a nationwide study in France. Taking only the anti-VEGF injections into account, 1.67 million injections were evaluated from the French medical-administrative database.…”
Section: Intraocular Inflammation and Endophthalmitismentioning
confidence: 99%
“…The prefilled ranibizumab syringe therefore had decreased the rate of endophthalmitis by 40% compared with ranibizumab in a vial and by 46% for aflibercept in a vial. 41 Storey et al analysed 243 754 injections of ranibizumab in 10 centers in the USA (2016 to 2017) and Japan (2009 to 2017). 42 The suspected rate of endophthalmitis with an injection of ranibizumab in a vial was 0.026%, the rate of culture-positive endophthalmitis was 0.013%.…”
Section: Intraocular Inflammation and Endophthalmitismentioning
confidence: 99%
“…Both studies suggest that the endophthalmitis rate can be significantly reduced by prefilled syringes. 41,42 The main reason for decreased risk of endophthalmitis while using prefilled syringes is due to lack of need for transfer of drug into another syringe, thus reducing the manipulations. This results in improved safety.…”
Section: Intraocular Inflammation and Endophthalmitismentioning
Purpose: To provide an update of summary of risk factors and side effects of long-term use and contamination of intravitreal anti-VEGF injections. Methods: We reviewed relevant publications of the topic of contamination of anti-VEGF injections and long-term side effects due to this reason. Results: Due to the long-term use of anti-VEGF drugs and the higher number of injections worldwide, various studies have shown side effects in recent years, ranging from increased intraocular pressure to visual disturbing silicone oil vesicles in the vitreous cavity. Several studies have demonstrated that both the drug and the processing, storage, environmental factors and the material and design of the syringes have a decisive influence on these side effects.Conclusion: The risks of deposits from syringes in the eye can be significantly reduced by various optimizations in transport, storage and syringe and cannula selection.
“…Two large population-based studies have been published in recent years analyzing the endophthalmitis rate after intravitreal injection. 41,42 Baudin et al evaluated the incidence of acute endophthalmitis after intravitreal injection of corticosteroids or anti-VEGF agents in a nationwide study in France. Taking only the anti-VEGF injections into account, 1.67 million injections were evaluated from the French medical-administrative database.…”
Section: Intraocular Inflammation and Endophthalmitismentioning
confidence: 99%
“…The prefilled ranibizumab syringe therefore had decreased the rate of endophthalmitis by 40% compared with ranibizumab in a vial and by 46% for aflibercept in a vial. 41 Storey et al analysed 243 754 injections of ranibizumab in 10 centers in the USA (2016 to 2017) and Japan (2009 to 2017). 42 The suspected rate of endophthalmitis with an injection of ranibizumab in a vial was 0.026%, the rate of culture-positive endophthalmitis was 0.013%.…”
Section: Intraocular Inflammation and Endophthalmitismentioning
confidence: 99%
“…Both studies suggest that the endophthalmitis rate can be significantly reduced by prefilled syringes. 41,42 The main reason for decreased risk of endophthalmitis while using prefilled syringes is due to lack of need for transfer of drug into another syringe, thus reducing the manipulations. This results in improved safety.…”
Section: Intraocular Inflammation and Endophthalmitismentioning
Purpose: To provide an update of summary of risk factors and side effects of long-term use and contamination of intravitreal anti-VEGF injections. Methods: We reviewed relevant publications of the topic of contamination of anti-VEGF injections and long-term side effects due to this reason. Results: Due to the long-term use of anti-VEGF drugs and the higher number of injections worldwide, various studies have shown side effects in recent years, ranging from increased intraocular pressure to visual disturbing silicone oil vesicles in the vitreous cavity. Several studies have demonstrated that both the drug and the processing, storage, environmental factors and the material and design of the syringes have a decisive influence on these side effects.Conclusion: The risks of deposits from syringes in the eye can be significantly reduced by various optimizations in transport, storage and syringe and cannula selection.
“…2 Baudin et al and our studies also found a 29% and 30% increased risk of endophthalmitis in women, repsectively. 1,2 These represent the first reports linking gender to endophthalmitis rates. Interestingly, despite age, gender and race almost uniformly being controlled for in other ophthalmic assessments (even when no demonstrable link exists to do so), gender has often been over-looked with regards to endophthalmitis after intravitreal injections.…”
mentioning
confidence: 93%
“…Two recent studies have provided several new interesting findings that further our understanding of the risk factors associated with post-injection endophthalmitis. 1,2 While these findings are novel to many of us, it is possible Genentech suspected this issue would arise as they have already received FDA approval and distributed pre-packaged syringes for both their 0.5mg(October 2016) and 0.3mg(March, 2108) doses of ranibizumab. Together, these studies offer compelling evidence that a policy mandating the sterile packaging of all intravitreal injections needs to be strongly considered.…”
Recently two studies from different countries using different datasets reported remarkably similar findings with regards to risk of endophthalmitis after intravitreal injections of antivascular endothelial growth factor(anti-VEGF) agents. The first study, published in JAMA Ophthalmology by Baudin and colleagues was conducted using the French national medicaladministrative database covering roughly 66 million people from 2012-2015. 1 They found that factory prepared syringes of ranibizumab decreased endophthalmitis compared to office prepared injections(ranibizumab IRR:1.40 & aflibercept IRR=1.46). 1 Less than a month later, we published a second study in the journal Retina using a similar sized U.S. insurance database covering the years 2005-2016, finding that using office-filled ranibizumab and aflibercept increased the odds of endophthalmitis(OR=1.29) compared to sterilely compounded bevacizumab. 2 Baudin et al. also found a similarly increased post-injection risk of endophthalmitis for women compared to men(IRR=1.28) as our paper did(OR=1.30). 1,2
IMPORTANCECompared with the operating room (OR), office-based intravitreal injection (IVI) is considered a more cost-effective and convenient approach, yet clinical outcomes of IVIs with anti-vascular endothelial growth factor (VEGF) agents in different settings (office-based vs OR) have not been systematically evaluated.OBJECTIVE To evaluate the safety outcomes of IVI with anti-VEGF agents in the OR vs office-based setting.DATA SOURCES PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov were searched from inception to July 2020.STUDY SELECTION Eligible studies reporting on patients who received IVIs with anti-VEGF drugs with a clearly stated injection setting of the office or OR.DATA EXTRACTION AND SYNTHESIS Two reviewers independently screened studies, extracted data, and assessed risk of bias. A meta-analysis was conducted to determine the rates of endophthalmitis (EO) and culture-positive EO.
MAIN OUTCOMES AND MEASURESRates of EO and culture-positive EO following anti-VEGF IVIs in the OR and office-based setting.RESULTS Thirty-one studies with a total of 1 275 815 injections were included. Comparative analysis suggested no difference between rates of EO after IVIs performed in the office and OR settings (odds ratio, 3.06; 95% CI, 0.07-139.75; P = .57; I 2 = 80%) were identified, yet a higher rate of culture-positive EO was found in the office setting (odds ratio, 21.52; 95% CI,; P = .006; I 2 = 0%). The pooled rates of EO following anti-VEGF IVIs were 0.03% (95% CI, 0.03-0.04) and 0.02% (95% CI, 0.01-0.04) in office and OR settings, respectively, and the pooled rates of culture-positive EO were 0.01% (95% CI, 0.01-0.02) and 0.01% (95% CI, 0-0.02). The pooled rates of other ocular and systemic adverse events were low.
CONCLUSIONS AND RELEVANCEThe rate of clinically suspected or culture-positive EO following anti-VEGF IVIs was low whether the procedure was performed in the office or OR setting. Bacterial spectrum could differ between the 2 settings. This meta-analysis could not determine if it is more appropriate to give treatment in the OR for safety reasons in low-income compared with higher-income regions in the world.
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