Clinical trial NCT00508040: Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a
Official title: Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Birdshot Chorioretinopathy
Cystoid Macular Edema
Transient Partial Visual Loss
Keywords: Birdshot Retine choroidopathy
Macular edema
Prednisone
Interferon alpha 2a
Associated with Cystoid macular edema
With Visual acuity loss
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreasing in macular-center thickness measured with optical coherence tomography
timeFrame: during 4 months
Secondary outcomes:
measure: Increasing in best corrected visual acuity
timeFrame: at 4 months and at the end of the study
measure: Final best corrected visual acuity in ETDRS scale
timeFrame: at the 4 month and at the end of the study
measure: Retinal vessels inflammation in fluorescein angiography
timeFrame: at the 4 month and at the end of the study
measure: Choroidal inflammation in indocyanine green angiography
timeFrame: at the 4 month and at the end of the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christine FARDEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotter I, Gunaydin I, Zierhut M, Stubiger N. The use of interferon alpha in Behcet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. doi: 10.1016/j.semarthrit.2003.09.010.