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Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial
  1. Erin C O’Neil1,
  2. Jiayan Huang2,
  3. Eric B Suhler3,
  4. James P Dunn Jr4,5,
  5. Victor L Perez6,
  6. David C Gritz5,
  7. Kathy McWilliams2,
  8. Ellen Peskin2,
  9. Gui-shuang Ying2,7,
  10. Vatinee Y Bunya1,
  11. Maureen G Maguire2,7,
  12. John H Kempen6,8,9,10
  1. 1 Department of Ophthalmology, Scheie Eye Institute, Philadelphia, Pennsylvania, USA
  2. 2 Department of Ophthalmology, Center for Preventive Ophthalmology and Biostatistics, Philadelphia, Pennsylvania, USA
  3. 3 Department of Ophthalmology, Oregon Health and Sciences University, Portland, Oregon, USA
  4. 4 Mid-Atlantic Retina, Wills Eye Hospital, Philadelphia, Pennsylvania, USA
  5. 5 Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA
  6. 6 Bascom Palmer Eye Institute, University of Miami, Miami, Florida, USA
  7. 7 Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
  8. 8 Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA
  9. 9 Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA
  10. 10 Discovery Eye Center, MyungSung Christian Medical Center, Addis Ababa, Ethiopia
  1. Correspondence to Professor John H Kempen, Ophthalmology and Epidemiology, University of Pennsylvania, Philadelphia, PA 19104, USA; kempenjh{at}yahoo.com

Abstract

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.

  • Clinical Trial
  • Drugs
  • Sclera and Episclera
  • Treatment other

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Footnotes

  • Contributors Conception and design of study: JHK. Acquisition of data: JHK, EBS, VLP, JPD, DCG, EP, KMW. Analysis and/or interpretation of data: JH, MGM, GY, JHK. Drafting the manuscript: ECON, JHK. All authors contributed to the revision of the manuscript, and approved the version of the manuscript to be published.

  • Funding The study was funded by FDA R01FD3910 (JHK). Additional financial support and product donation were received from EyeGate Pharmaceuticals (JHK).

  • Disclaimer The funding organisations had no role in the design or conduct of this research.

  • 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.

  • Patient consent Not required.

  • Ethics approval Institutional Review Board at all participating institutions.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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