Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a (BIRDFERON)
Primary Purpose
Birdshot Chorioretinopathy, Cystoid Macular Edema, Transient Partial Visual Loss
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
interferon alpha 2a
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Birdshot Chorioretinopathy focused on measuring Birdshot Retine choroidopathy, Macular edema, Prednisone, Interferon alpha 2a, Associated with Cystoid macular edema, With Visual acuity loss
Eligibility Criteria
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
Sites / Locations
- Hopital La Pitie Salpetriere
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm 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.
Outcomes
Primary Outcome Measures
Decreasing in macular-center thickness measured with optical coherence tomography
Secondary Outcome Measures
Increasing in best corrected visual acuity
Final best corrected visual acuity in ETDRS scale
Retinal vessels inflammation in fluorescein angiography
Choroidal inflammation in indocyanine green angiography
Full Information
NCT ID
NCT00508040
First Posted
July 26, 2007
Last Updated
January 22, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00508040
Brief Title
Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a
Acronym
BIRDFERON
Official Title
Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm 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.
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
interferon alpha 2a
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decreasing in macular-center thickness measured with optical coherence tomography
Time Frame
during 4 months
Secondary Outcome Measure Information:
Title
Increasing in best corrected visual acuity
Time Frame
at 4 months and at the end of the study
Title
Final best corrected visual acuity in ETDRS scale
Time Frame
at the 4 month and at the end of the study
Title
Retinal vessels inflammation in fluorescein angiography
Time Frame
at the 4 month and at the end of the study
Title
Choroidal inflammation in indocyanine green angiography
Time Frame
at the 4 month and at the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine FARDEAU, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15079763
Citation
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.
Results Reference
result
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Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a
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