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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01379196
Recruitment Status : Withdrawn (Patients were not interested in enrolling)
First Posted : June 23, 2011
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
kalish hadas, Rabin Medical Center

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
Graves Ophthalmopathy Drug: Azithromycin 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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 Name: AZITRO

Primary Outcome Measures :
  1. Change in clinical activity score between baseline and after three months [ Time Frame: 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 [ Time Frame: 3 months ]
    Ultrasonic measurement of extraocular muscle thickening

  2. ANTI TSH Receptor antibody levels [ Time Frame: 0, 3 and 6 months ]
    Serum measurements of ANTI TSH Receptor antibody levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01379196

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

Responsible Party: kalish hadas, Chief, Neuro-Ophthalmology Unit, Rabin Medical Center Identifier: NCT01379196     History of Changes
Other Study ID Numbers: 0427-10-RMC
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by kalish hadas, Rabin Medical Center:
Graves Orbitopathy
Macrolide antibiotics
Clinical Activity Score

Additional relevant MeSH terms:
Graves Ophthalmopathy
Graves Disease
Eye Diseases
Eye Diseases, Hereditary
Orbital Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases