Clinical Trial: Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a

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

Official Title: Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a

Brief Summary: Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.

Detailed Summary:

Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.

The conventional therapy includes in first line steroid therapy of which side effects are well known. If the daily steroid dose necessary to control the intra ocular inflammation is superior to 0.3 mg/kg/d a combined therapy to immunosuppressive drug is suggested in order to do a steroid sparing effect. Immunosuppressive drugs include increased infectious risks, hematologic and sterility troubles, and secondary malignancies. Moreover immunosuppressive drugs have a own toxic effect and The classical immunosuppressive drug used in BRC the cyclosporineA has a high level of nephrotoxicity.

That is the reason why immunomodulatory drugs as interferons have been suggested in BRC.

Interferon alpha2 a has been shown efficient in uveitis in Behcet's disease. We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not make the disease worse because of the slow pathologic processus.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Decreasing in macular-center thickness measured with optical coherence tomography [ Time Frame: during 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Increasing in best corrected visual acuity [ Time Frame: at 4 months and at the end of the study ]
  • Final best corrected visual acuity in ETDRS scale [ Time Frame: at the 4 month and at the end of the study ]
  • Retinal vessels inflammation in fluorescein angiography [ Time Frame: at the 4 month and at the end of the study ]
  • Choroidal inflammation in indocyanine green angiography [ Time Frame: at the 4 month and at the end of the study ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 26, 2007
Date Started: September 2007
Date Completion:
Last Updated: January 22, 2013
Last Verified: October 2008