Purpose: To analyze a case series of retinal vasculitis reported to the American Society of Retina Specialists (ASRS) following Food and Drug Administration approval of brolucizumab for treatment of neovascular age-related macular degeneration. Methods: The ASRS Research and Safety in Therapeutics Committee analyzed clinical and imaging characteristics from submitted reports of retinal vasculitis after brolucizumab. Results: Retinal vasculitis was reported in 26 eyes of 25 patients (22 [88%] female) after treatment with brolucizumab. Imaging studies were available for 24 of 26 eyes. Most cases (92%) were associated with intraocular inflammation, which presented at a mean of 25 days (range, 3-63 days) after the most recent brolucizumab injection. Mean visual acuity (VA) was 20/52 (range, 20/25-4/200) before the adverse event, 20/151 (range, 20/25-hand motion) at presentation of the adverse event, and 20/243 (range, 20/30-light perception) at last follow-up. Twelve eyes (46%) had a greater than 3-line decrease in VA at final follow-up, and 12 eyes (46%) had a final VA of 20/200 or worse. Analysis of retinal imaging identified vasculopathy that involved retinal arteries (91%), retinal veins (79%), and choroidal vessels (48%). Occlusive disease was apparent on imaging in 83% of eyes. Treatment approaches were varied. Conclusions: Retinal vasculitis has been identified in a series of eyes following brolucizumab. Although a few eyes in this series were asymptomatic or minimally symptomatic, some eyes had significant vision loss. A careful examination for signs of active inflammation prior to brolucizumab injection is recommended. Once vasculopathy is suspected, angiographic imaging may help define the spectrum of involvement. Optimal treatment strategies remain unknown.
Purpose
To report a series of patients with Streptococcus endophthalmitis after injection with intravitreal bevacizumab prepared by the same compounding pharmacy.
Design
Non-comparative consecutive case series.
Methods
Medical records and microbiology results of patients who presented with endophthalmitis after injection with intravitreal bevacizumab between July 5 and July 8, 2011, were reviewed.
Results
Twelve patients were identified with endophthalmitis, presenting 1-6 days after receiving an intravitreal injection of bevacizumab. The injections occurred at four different locations in South Florida. All patients received bevacizumab prepared by the same compounding pharmacy. None of the infections originated at the Bascom Palmer Eye Institute, Miami, FL, although nine patients presented to its tertiary-care ophthalmic emergency room for treatment, and three additional patients were seen in consultation. All patients were treated initially with a vitreous tap and injection; eight patients subsequently received a vitrectomy. Microbiology cultures for ten patients were positive for Streptococcus mitis/oralis. Seven unused syringes of bevacizumab prepared by the compounding pharmacy at the same time as those prepared for the affected patients also were positive for S. mitis/oralis. After four months of follow-up, all but one patient had count-fingers or worse visual acuity, and three required evisceration or enucleation. Local, state and federal health department officials have been investigating the source of the contamination.
Conclusions
In this outbreak of endophthalmitis after intravitreal bevacizumab injection, Streptococcus mitis/oralis was cultured from the majority of patients and from all unused syringes. Visual outcomes were generally poor. The most likely cause of this outbreak was contamination during syringe preparation by the compounding pharmacy.
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