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

Cystoid Macular Edema Clinical Trial

— BIRDFERON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508040
• Other study ID #: P051032
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2007
• Last updated: January 22, 2013
• Start date: September 2007
• Est. completion date: January 2013

Study information

• Verified date: October 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birdshot Chorioretinopathy
• Chorioretinitis
• Cystoid Macular Edema
• Macular Edema
• Transient Partial Visual Loss

Intervention

Drug:
• interferon alpha 2a
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
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.

Locations

Country	Name	City	State
France	Hopital La Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Kötter I, Günaydin I, Zierhut M, Stübiger N. The use of interferon alpha in Behçet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreasing in macular-center thickness measured with optical coherence tomography		during 4 months	Yes
Secondary	Increasing in best corrected visual acuity		at 4 months and at the end of the study	Yes
Secondary	Final best corrected visual acuity in ETDRS scale		at the 4 month and at the end of the study	Yes
Secondary	Retinal vessels inflammation in fluorescein angiography		at the 4 month and at the end of the study	Yes
Secondary	Choroidal inflammation in indocyanine green angiography		at the 4 month and at the end of the study	Yes