Clinical Trial: Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uv

Brief Summary: The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.

Detailed Summary:

Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.

Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .


Sponsor: Heidelberg University

Current Primary Outcome: Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12 [ Time Frame: at month 1,3,6 and 12 ]

Original Primary Outcome: Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12

Current Secondary Outcome:

  • Reduction of macular edema (OCT) [ Time Frame: at month 1,3,6 and 12 ]
  • Reduction intraocular inflammation (2 step change, SUN classification) [ Time Frame: at month 1,3,6 and 12 ]
  • Increase in retinal light sensitivity (fundus controlled perimetry) [ Time Frame: at month 1,3 and 12 ]


Original Secondary Outcome:

  • Reduction of macular edema (OCT)at month 1,3,6 and 12
  • Reduction intraocular inflammation (2 step change, SUN classification)at month 1,3,6 and 12
  • Increase in retinal light sensitivity (fundus controlled perimetry)at month 1,3 and 12


Information By: Heidelberg University

Dates:
Date Received: June 22, 2006
Date Started: March 2006
Date Completion:
Last Updated: November 30, 2012
Last Verified: November 2012