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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Birdshot Chorioretinopathy, Cystoid Macular Edema, Transient Partial Visual Loss

Intervention / Treatment
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* Drug: interferon alpha 2a
* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>To analyse the potential therapeutic effect of Interferon alpha2a 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. | Drug: interferon alpha 2a<br>* 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.<br>Drug: prednisone<br>* 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.<br>|
| Active Comparator: B<br> | Drug: interferon alpha 2a<br>* 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.<br>Drug: prednisone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing in macular-center thickness measured with optical coherence tomography |  | during 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increasing in best corrected visual acuity |  | at 4 months and at the end of the study | 
| Final best corrected visual acuity in ETDRS scale |  | at the 4 month and at the end of the study | 
| Retinal vessels inflammation in fluorescein angiography |  | at the 4 month and at the end of the study | 
| Choroidal inflammation in indocyanine green angiography |  | at the 4 month and at the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birdshot Retine choroidopathy, Macular edema, Prednisone, Interferon alpha 2a, Associated with Cystoid macular edema, With Visual acuity loss