NCT00508040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 23, 2013

Status Verified

October 1, 2008

Enrollment Period

4.1 years

First QC Date

July 26, 2007

Last Update Submit

January 22, 2013

Conditions

Birdshot ChorioretinopathyCystoid Macular EdemaTransient Partial Visual Loss

Keywords

Birdshot Retine choroidopathyMacular edemaPrednisoneInterferon alpha 2aAssociated with Cystoid macular edemaWith Visual acuity loss

Outcome Measures

Primary Outcomes (1)

  • Decreasing in macular-center thickness measured with optical coherence tomography

    during 4 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

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.

Drug: interferon alpha 2aDrug: prednisone

B

ACTIVE COMPARATOR
Drug: interferon alpha 2aDrug: prednisone

Interventions

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.

AB
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.

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Birdshot Retine choroidopathy with macular edema
  • HLA A29 positive
  • Work up of infection or sarcoidosis disease negative

You may not qualify if:

  • Pregnancy
  • Alcohol addiction
  • Mood disturbance
  • Medullar, hepatic, renal deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital La Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (1)

  • 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: 15079763RESULT

MeSH Terms

Conditions

Birdshot ChorioretinopathyMacular Edema

Interventions

Interferon alpha-2Prednisone

Condition Hierarchy (Ancestors)

ChorioretinitisRetinitisRetinal DiseasesEye DiseasesChoroiditisChoroid DiseasesUveal DiseasesUveitis, PosteriorPanuveitisUveitisWhite Dot SyndromesAutoimmune DiseasesImmune System DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Christine FARDEAU, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2011

Study Completion

January 1, 2013

Last Updated

January 23, 2013

Record last verified: 2008-10

Locations

FR(1)