Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial
Erin C O'Neil, Jiayan Huang, Eric B Suhler, James P Dunn Jr, Victor L Perez, David C Gritz, Kathy McWilliams, Ellen Peskin, Gui-Shuang Ying, Vatinee Y Bunya, Maureen G Maguire, John H Kempen, Erin C O'Neil, Jiayan Huang, Eric B Suhler, James P Dunn Jr, Victor L Perez, David C Gritz, Kathy McWilliams, Ellen Peskin, Gui-Shuang Ying, Vatinee Y Bunya, Maureen G Maguire, John H Kempen
Abstract
Currently available treatment options for non-infectious scleritis, including non-steroidal anti-inflammatory drugs, systemic corticosteroids and immunosuppressive therapies, have both efficacy and side effect limitations. Iontophoretic delivery of corticosteroids has been demonstrated to be effective for anterior uveitis and represents a potential new approach to scleritis therapy. We hypothesised that iontophoretic delivery would provide effective and precise medication delivery to the sclera, while limiting systemic exposure and side effects. This first-in-human randomised, double-masked, dose-escalating study of iontophoretic administration of dexamethasone phosphate for scleritis suggests the treatment to be well tolerated and safe (within the limitations of the 18 patients sample size). There was a suggestion of efficacy in the lowest (1.2 mA/min at 0.4 mA) dose group (corresponding to the superficial location of scleritis compared with anterior uveitis), with 5/7 eyes meeting the primary efficacy outcome within 28 days. Our results suggest iontophoretic delivery of corticosteroids is a promising potential treatment for scleritis, with favourable safety and preliminary efficacy results in this phase 1 trial.
Trial registration number: NCT01059955.
Keywords: Clinical Trial; Drugs; Sclera and Episclera; Treatment other.
Conflict of interest statement
Competing interests: The study was secondarily funded and the study treatment was provided by EyeGate Pharma. JHK and JPD have served as consultants in the last 12 months for AbbVie.
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Source: PubMed