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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Birdshot Chorioretinopathy; Transient Partial Visual Loss; Cystoid Macular Edema

Treatments: Drug: prednisone; Drug: interferon alpha 2a

Study type: Interventional

Funder types: Other

Identifiers

NCT00508040

P051032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

A

Experimental group

Description:

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.

Treatment:

Drug: prednisone

Drug: interferon alpha 2a

B

Active Comparator group

Treatment:

Drug: prednisone

Drug: interferon alpha 2a