Original article
The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab

https://doi.org/10.1016/j.ajo.2018.11.023Get rights and content

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.

Section snippets

Overview

This multicenter retrospective comparative cohort study was prospectively approved by the Wills Eye Hospital Institutional Review Board as well as institutional review boards at each of the 10 participating centers. The study adhered to the tenets of the Declaration of Helsinki. Billing records were used to retrospectively identify all cases of endophthalmitis secondary to intravitreal injection of 0.5 mg ranibizumab (Genentech, South San Francisco, California, USA) in both conventional vials

Rate of Endophthalmitis

During our study period, a total of 243 754 intravitreal injections of ranibizumab were administered to 43132 unique patients across all 10 institutions. Average patient age was 80.3 years and 61.5% of patients were female. Treatment indication was neovascular AMD for 82.1% of injections, branch retinal vein occlusion (BRVO) 7.9%, central retinal vein occlusion (CRVO) 5.3%, DME 0.5%, and other pathologies 4.2%, including myopic choroidal neovascularization. Overall, a total of 55 patients were

Discussion

Endophthalmitis following intravitreal injection remains an uncommon event. Any prophylaxis measure that might lower the risk of infection requires assessment of a large number of injections in order to achieve adequate power to detect a significantly decreased risk. In our study of 10 institutions across the United States and Japan, we assessed endophthalmitis rates after nearly 250 000 intravitreal ranibizumab injections with detailed confirmation of the diagnosis and clinical course.

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