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

NCT00508040 — Phase 2, Completed, 58 participants, Assistance Publique - Hôpitaux de Paris

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

RegistryNCT00508040, acronym BIRDFERON
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment58 (Actual)
SponsorAssistance Publique - Hôpitaux de Paris (Other)
ConditionsBirdshot Chorioretinopathy, Cystoid Macular Edema, Transient Partial Visual Loss
Interventionsinterferon alpha 2a, prednisone (Drug)
Datesstart 2007-09-01, primary completion 2011-10-01, completion 2013-01-01, first posted 2007-07-27, last updated 2013-01-23
Locations1 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
AExperimentalDrug: interferon alpha 2a; Drug: prednisoneTo 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.
BActive comparatorDrug: interferon alpha 2a; Drug: prednisone
  • interferon alpha 2a (Drug): 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 (Drug): 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.

+Outcome measures

Primary outcomes

  • Decreasing in macular-center thickness measured with optical coherence tomography [during 4 months]

Secondary outcomes

  • 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]

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Hopital La Pitie SalpetriereParisFrance

+Publications

  • Results publication: Kotter I, Gunaydin I, Zierhut M, Stubiger N. The use of interferon alpha in Behcet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. doi: 10.1016/j.semarthrit.2003.09.010. PMID 15079763

+Investigators

  • Christine FARDEAU, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris