Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a (BIRDFERON)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Birdshot Chorioretinopathy Cystoid Macular Edema Transient Partial Visual Loss |
Drug: interferon alpha 2a Drug: prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a |
- Decreasing in macular-center thickness measured with optical coherence tomography [ Time Frame: during 4 months ] [ Designated as safety issue: Yes ]
- Increasing in best corrected visual acuity [ Time Frame: at 4 months and at the end of the study ] [ Designated as safety issue: Yes ]
- Final best corrected visual acuity in ETDRS scale [ Time Frame: at the 4 month and at the end of the study ] [ Designated as safety issue: Yes ]
- Retinal vessels inflammation in fluorescein angiography [ Time Frame: at the 4 month and at the end of the study ] [ Designated as safety issue: Yes ]
- Choroidal inflammation in indocyanine green angiography [ Time Frame: at the 4 month and at the end of the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 58 |
| Study Start Date: | September 2007 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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.
|
Drug: interferon alpha 2a
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.
Other Name: interferon alpha 2a
Drug: prednisone
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.
Other Name: prednisone
|
| Active Comparator: B |
Drug: interferon alpha 2a
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.
Other Name: interferon alpha 2a
Drug: prednisone
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.
Other Name: prednisone
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| France | |
| Hopital La Pitie Salpetriere | |
| Paris, France, 75013 | |
| Principal Investigator: | Christine FARDEAU, MD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00508040 History of Changes |
| Other Study ID Numbers: | P051032 |
| Study First Received: | July 26, 2007 |
| Last Updated: | January 22, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Birdshot Retine choroidopathy Macular edema Prednisone |
Interferon alpha 2a Associated with Cystoid macular edema With Visual acuity loss |
Additional relevant MeSH terms:
|
Choroid Diseases Edema Macular Edema Vision, Low Chorioretinitis Uveal Diseases Eye Diseases Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases |
Retinitis Choroiditis Uveitis, Posterior Panuveitis Uveitis Interferon-alpha Interferon Alfa-2a Interferons Prednisone Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013