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

This study has been withdrawn prior to enrollment.
(Patients were not interested in enrolling)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379196
First Posted: June 23, 2011
Last Update Posted: April 27, 2017
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.
Information provided by (Responsible Party):
kalish hadas, Rabin Medical Center
May 11, 2011
June 23, 2011
April 27, 2017
May 2011
November 2014   (Final data collection date for primary outcome measure)
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.

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 ]
    Ultrasonic measurement of extraocular muscle thickening
  • ANTI TSH Receptor antibody levels [ Time Frame: 0, 3 and 6 months ]
    Serum measurements of ANTI TSH Receptor antibody levels
Same as current
Not Provided
Not Provided
 
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Graves Ophthalmopathy
Drug: Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Other Name: AZITRO
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.
 
Withdrawn
0
December 2014
November 2014   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01379196
0427-10-RMC
Yes
Not Provided
Plan to Share IPD: Undecided
kalish hadas, Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Hadas Kalish, MD Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
Rabin Medical Center
April 2017

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