Birdshot ChorioretinopathyPhase 2BIRDFERONNCT00508040
Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a
A Phase 2 study testing interferon alpha 2a and prednisone in people with Birdshot Chorioretinopathy and Cystoid Macular Edema, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Birdshot Chorioretinopathy, Cystoid Macular Edema, Transient Partial Visual Loss
- What is being tested?
- interferon alpha 2a and prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Birdshot Retine choroidopathy with macular edema
- HLA A29 positive
- Work up of infection or sarcoidosis disease negative
Who cannot join
- Pregnancy
- Alcohol addiction
- Mood disturbance
- Medullar, hepatic, renal deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a
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.
Read the 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.
- Being tested
- interferon alpha 2a, prednisone
- Keywords
- Birdshot Retine choroidopathy, Macular edema, Prednisone, Interferon alpha 2a, Associated with Cystoid macular edema, With Visual acuity loss
- Medical subject headings
- Birdshot Chorioretinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon alpha 2aDrug
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.
prednisoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 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. Receives: Drug: interferon alpha 2a; Drug: prednisone |
| B | Active comparator | Not described Receives: Drug: interferon alpha 2a; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreasing in macular-center thickness measured with optical coherence tomography
Measured: during 4 months
Secondary outcomes (4)
Increasing in best corrected visual acuity
Measured: at 4 months and at the end of the study
Final best corrected visual acuity in ETDRS scale
Measured: at the 4 month and at the end of the study
Retinal vessels inflammation in fluorescein angiography
Measured: at the 4 month and at the end of the study
Choroidal inflammation in indocyanine green angiography
Measured: at the 4 month and at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birdshot ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine FARDEAU, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508040
- Sponsor's protocol ID
- P051032
- Acronym
- BIRDFERON
- Status last verified
- Oct 2008
- First submitted
- 26 Jul 2007
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15079763
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a
- ClinicalTrials.gov ID
- NCT00508040
- Acronym / sponsor ID
- BIRDFERON / P051032
- Keywords
- Birdshot Retine choroidopathy, Macular edema, Prednisone, Interferon alpha 2a, Associated with Cystoid macular edema, With Visual acuity loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 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. |
| B | Active comparator | Drug: interferon alpha 2a, Drug: prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Birdshot Retine choroidopathy with macular edema
- HLA A29 positive
- Work up of infection or sarcoidosis disease negative
Key exclusion criteria (4 listed)
- Pregnancy
- Alcohol addiction
- Mood disturbance
- Medullar, hepatic, renal deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon alpha 2aWe 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. | Drug | A, B |
| prednisoneWe 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. | Drug | A, B |
Primary outcome
Decreasing in macular-center thickness measured with optical coherence tomography
Time frame: during 4 months
4 secondary outcomes
Increasing in best corrected visual acuity
Time frame: at 4 months and at the end of the study
Final best corrected visual acuity in ETDRS scale
Time frame: at the 4 month and at the end of the study
Retinal vessels inflammation in fluorescein angiography
Time frame: at the 4 month and at the end of the study
Choroidal inflammation in indocyanine green angiography
Time frame: at the 4 month and at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Results publication: PubMed 15079763Kotter 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.
Related trials for Birdshot Chorioretinopathy
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Birdshot Chorioretinopathy, Posterior Uveitis
RecruitingObservational study
Quantification & Classification of Inflammatory Cells in Uveitis Using OCT
Anterior Uveitis (AU), Birdshot Chorioretinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine FARDEAU, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon alpha 2a and prednisone in people with Birdshot Chorioretinopathy and Cystoid Macular Edema, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreasing in macular-center thickness measured with optical coherence tomography (time frame: during 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.