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. 2018 Aug;102(8):1011-1013.
doi: 10.1136/bjophthalmol-2017-311610. Epub 2018 Apr 17.

Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial

Erin C O'Neil  1 , Jiayan Huang  2 , Eric B Suhler  3 , James P Dunn Jr  4   5 , Victor L Perez  6 , David C Gritz  5 , Kathy McWilliams  2 , Ellen Peskin  2 , Gui-Shuang Ying  2   7 , Vatinee Y Bunya  1 , Maureen G Maguire  2   7 , John H Kempen  8   9   10   11
Affiliations

Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial

Erin C O'Neil et al. Br J Ophthalmol. 2018 Aug.

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.

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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.

References

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