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Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy

Primary Purpose

Graves Ophthalmopathy

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Ophthalmopathy focused on measuring Graves Orbitopathy, Macrolide antibiotics, Inflammation, Clinical Activity Score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Graves Orbitopathy
  • Clinical activity score higher than 2
  • Must be able to swallow tablets

Exclusion Criteria:

  • sight-threatening Graves Orbitopathy
  • Diplopia in primary gaze
  • Macrolide allergy or intolerance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Azithromycin PO three times weekly

    Arm Description

    Tablets Azithromycin 500 mg PO three times weekly for three months

    Outcomes

    Primary Outcome Measures

    Change in clinical activity score between baseline and after three months
    Change in the clinical activity score between baseline and after 3 months (Clinical Activity Score is a validated index of Graves Ophthalmopathy that assigns one point to the presence of: 1.spontaneous retrobulbar pain, 2. pain on up/downgaze, 3. redness of eyelids, 4. redness of conjunctiva, 5. swelling of eyelids, 6. inflammation of caruncle/plica, 7. chemosis). The maximal clinical activity score is thus 7.

    Secondary Outcome Measures

    Measurement of extraocular muscle thickening
    Ultrasonic measurement of extraocular muscle thickening
    ANTI TSH Receptor antibody levels
    Serum measurements of ANTI TSH Receptor antibody levels

    Full Information

    First Posted
    May 11, 2011
    Last Updated
    April 25, 2017
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01379196
    Brief Title
    Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
    Official Title
    Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Patients were not interested in enrolling
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy. Indices for follow-up will include: Clinical activity score Anti-TSH receptor antibody levels Thickening of extraocular muscles per ultrasound Quality of life score for Graves Orbitopathy patients
    Detailed Description
    Graves Orbitopathy (GO) is an autoimmune inflammatory disorder causing visual morbidity, cosmetic morbidity and interference with quality of life. The disease has an inflammatory stage and a non-inflammatory, fibrotic stage. Treatment of inflammatory stage moderate-severe GO includes steroids, as recommended by the EUGOGO consortium. However, the length of treatment needed and the risk of steroid side-effects may lead to multiple undesired treatment induced morbidity. Antibiotics of the macrolide group posses known immune-modulatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of macrolide antibiotics for delaying graft rejection following lung transplants. We propose to test the effect of this class of antibiotics for non-sight threatening, moderate-severe, inflammatory GO.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graves Ophthalmopathy
    Keywords
    Graves Orbitopathy, Macrolide antibiotics, Inflammation, Clinical Activity Score

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Azithromycin PO three times weekly
    Arm Type
    Experimental
    Arm Description
    Tablets Azithromycin 500 mg PO three times weekly for three months
    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin
    Other Intervention Name(s)
    AZITRO
    Intervention Description
    Tab. Azithromycin 500 mg PO three times weekly for 3 months
    Primary Outcome Measure Information:
    Title
    Change in clinical activity score between baseline and after three months
    Description
    Change in the clinical activity score between baseline and after 3 months (Clinical Activity Score is a validated index of Graves Ophthalmopathy that assigns one point to the presence of: 1.spontaneous retrobulbar pain, 2. pain on up/downgaze, 3. redness of eyelids, 4. redness of conjunctiva, 5. swelling of eyelids, 6. inflammation of caruncle/plica, 7. chemosis). The maximal clinical activity score is thus 7.
    Time Frame
    Three months
    Secondary Outcome Measure Information:
    Title
    Measurement of extraocular muscle thickening
    Description
    Ultrasonic measurement of extraocular muscle thickening
    Time Frame
    3 months
    Title
    ANTI TSH Receptor antibody levels
    Description
    Serum measurements of ANTI TSH Receptor antibody levels
    Time Frame
    0, 3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Graves Orbitopathy Clinical activity score higher than 2 Must be able to swallow tablets Exclusion Criteria: sight-threatening Graves Orbitopathy Diplopia in primary gaze Macrolide allergy or intolerance
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hadas Kalish, MD
    Organizational Affiliation
    Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy

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