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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00508040
Acronym
BIRDFERON
Enrollment
58
Registered
2007-07-27
Start date
2007-09-30
Completion date
2013-01-31
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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.

DRUGprednisone

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Decreasing in macular-center thickness measured with optical coherence tomographyduring 4 months

Secondary

MeasureTime frame
Increasing in best corrected visual acuityat 4 months and at the end of the study
Final best corrected visual acuity in ETDRS scaleat the 4 month and at the end of the study
Retinal vessels inflammation in fluorescein angiographyat the 4 month and at the end of the study
Choroidal inflammation in indocyanine green angiographyat the 4 month and at the end of the study

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026