Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a
| Registry | NCT00508040, acronym BIRDFERON |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 58 (Actual) |
| Sponsor | Assistance Publique - Hôpitaux de Paris (Other) |
| Conditions | Birdshot Chorioretinopathy, Cystoid Macular Edema, Transient Partial Visual Loss |
| Interventions | interferon alpha 2a, prednisone (Drug) |
| Dates | start 2007-09-01, primary completion 2011-10-01, completion 2013-01-01, first posted 2007-07-27, last updated 2013-01-23 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Birdshot Chorioretinopathy All trials for Cystoid Macular Edema All trials of interferon alpha 2a All trials of prednisone
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| A | Experimental | Drug: interferon alpha 2a; Drug: 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 | Active comparator | Drug: interferon alpha 2a; Drug: prednisone |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hopital La Pitie Salpetriere | Paris | France |