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Karen R Armbrust, Austin Roy Fox, Brett G Jeffrey, Patti Sherry, Robert B Nussenblatt, H Nida Sen; Rituximab for Autoimmune Retinopathy. Invest. Ophthalmol. Vis. Sci. 2016;57(12):1858.
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© 2017 Association for Research in Vision and Ophthalmology.
Autoimmune retinopathy (AIR) is a rare posterior uveitis presumably caused by anti-retinal autoantibodies and characterized by progressive vision loss, with visual field loss and electroretinography (ERG) changes. There is no proven treatment for AIR. Rituximab is a monoclonal antibody that directs lysis of cells with the CD20 antigen, a transmembrane protein on B lymphocytes. The goal of this Phase I study is to determine whether rituximab, which targets destruction of antibody-producing cells, is a safe and potentially effective treatment for AIR.
Five AIR patients with visual acuity ≥ 20/200 in at least one eye were enrolled in this prospective, non-masked Phase I study. Rituximab was administered at days 0 and 15, and a second cycle of rituximab was administered 6-9 months later. Clinical evaluation was performed 6 and 12 weeks after each rituximab cycle and then every 3 months for a total study duration of 18 months. Treatment response was assessed by evaluating changes in ERG response amplitudes, Humphrey visual field (HVF) mean deviation (MD), and scotoma area on Goldmann visual field (GVF) testing; patients were grouped into treatment success, partial response, and treatment failure. The primary outcome was the number of subjects who fulfill study criteria for treatment success at month 6. Secondary outcomes included treatment success at months 9 and 12 and partial response at months 6, 9 and 12.
There were no drug-related adverse events. All subjects tolerated rituximab, and 4 subjects met study criteria for a partial response to rituximab at 6 months. One subject became a treatment failure at 6 months and another at 18 months for >3 dB reduction in HVF MD; this HVF decline was verified by GVF. The other subjects remained in the partial response category based on HVF. ERG amplitudes, assuming 25% variability, were stable during the study except for decreasing cone amplitudes OU in 1 subject and decreasing rod amplitudes OU and decreasing cone amplitudes OS in another subject. ERG implicit times were stable in all subjects.
This Phase I study shows that rituximab is well tolerated in AIR patients. Over the course of this small pilot study, visual field loss progressed in 2 of the 5 subjects and ERG amplitudes declined in 2 of the 5 subjects. Other tested parameters were stable.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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