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

Phase 2

Completed

• Conditions: Birdshot Chorioretinopathy; Cystoid Macular Edema; Transient Partial Visual Loss
• Interventions: Drug: interferon alpha 2a; Drug: prednisone

• Registration Number: NCT00508040
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Study Start: 2007-09
• Status Verified: 2008-10
• Primary Completion: 2011-10
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	interferon alpha 2a	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.
B	interferon alpha 2a	-
A	prednisone	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.
B	prednisone	-

Primary Outcome Measures

Name	Time	Method
Decreasing in macular-center thickness measured with optical coherence tomography	during 4 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital La Pitie Salpetriere; 🇫🇷 Paris, France