Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01379196
First received: May 11, 2011
Last updated: June 22, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Graves Ophthalmopathy
Drug: Azithromycin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Change in clinical activity score between baseline and after three months [ Time Frame: Three months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ultrasonic measurement of extraocular muscle thickening

  • ANTI TSH Receptor antibody levels [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
    Serum measurements of ANTI TSH Receptor antibody levels


Estimated Enrollment: 14
Study Start Date: May 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379196

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Hadas Kalish, MD Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
  More Information

No publications provided

Responsible Party: Hadas Stiebel-Kalish, MD, Chief, Neuro-Ophthalmology Unit,, Rabin Medical Center, Petah Tikva 49100, Israel
ClinicalTrials.gov Identifier: NCT01379196     History of Changes
Other Study ID Numbers: 0427-10-RMC
Study First Received: May 11, 2011
Last Updated: June 22, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Graves Orbitopathy
Macrolide antibiotics
Inflammation
Clinical Activity Score

Additional relevant MeSH terms:
Graves Ophthalmopathy
Graves Disease
Eye Diseases
Eye Diseases, Hereditary
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014