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

Sponsor
Rabin Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01379196
Collaborator
(none)
0
Enrollment
1
Arm
43
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azithromycin PO three times weekly

Tablets Azithromycin 500 mg PO three times weekly for three months

Drug: Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Other Names:
  • AZITRO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in clinical activity score between baseline and after three months [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

    1. Measurement of extraocular muscle thickening [3 months]

      Ultrasonic measurement of extraocular muscle thickening

    2. ANTI TSH Receptor antibody levels [0, 3 and 6 months]

      Serum measurements of ANTI TSH Receptor antibody levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • Principal Investigator: Hadas Kalish, MD, Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    kalish hadas, Chief, Neuro-Ophthalmology Unit, Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT01379196
    Other Study ID Numbers:
    • 0427-10-RMC
    First Posted:
    Jun 23, 2011
    Last Update Posted:
    Apr 27, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by kalish hadas, Chief, Neuro-Ophthalmology Unit, Rabin Medical Center
    Graves Orbitopathy
    Macrolide antibiotics
    Inflammation
    Clinical Activity Score
    Additional relevant MeSH terms:
    Eye Diseases
    Graves Ophthalmopathy
    Azithromycin

    Study Results

    No Results Posted as of Apr 27, 2017