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Completed

NCT Number: NCT00508040

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Birdshot Retine choroidopathy with macular edema
  • HLA A29 positive
  • Work up of infection or sarcoidosis disease negative

Exclusion criteria

  • Pregnancy
  • Alcohol addiction
  • Mood disturbance
  • Medullar, hepatic, renal deficiency

Treatment and study plan

interferon alpha 2a

Drug

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 expose to a worsening of the disease because of the slow pathologic processus.

Prednisone

Drug

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 expose to a worsening of the disease because of the slow pathologic processus.

Primary outcomes

  1. Decreasing in macular-center thickness measured with optical coherence tomography

    Time frame: during 4 months

Secondary outcomes

  1. Increasing in best corrected visual acuity

    Time frame: at 4 months and at the end of the study

  2. Final best corrected visual acuity in ETDRS scale

    Time frame: at the 4 month and at the end of the study

  3. Retinal vessels inflammation in fluorescein angiography

    Time frame: at the 4 month and at the end of the study

  4. Choroidal inflammation in indocyanine green angiography

    Time frame: at the 4 month and at the end of the study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: BIRDFERON

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Jul 27, 2007
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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