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

May 11, 2011
June 22, 2011
May 2011
July 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01379196 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy
Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy

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

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Graves Ophthalmopathy
Drug: Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Experimental: Azithromycin PO three times weekly
Tablets Azithromycin 500 mg PO three times weekly for three months
Intervention: Drug: Azithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
14
November 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01379196
0427-10-RMC
Yes
Hadas Stiebel-Kalish, MD, Chief, Neuro-Ophthalmology Unit,, Rabin Medical Center, Petah Tikva 49100, Israel
Rabin Medical Center
Not Provided
Principal Investigator: Hadas Kalish, MD Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
Rabin Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP