Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
|ClinicalTrials.gov Identifier: NCT01379196|
Recruitment Status : Withdrawn (Patients were not interested in enrolling)
First Posted : June 23, 2011
Last Update Posted : April 27, 2017
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|
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)|
|Official Title:||Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy|
|Study Start Date :||May 2011|
|Primary Completion Date :||November 2014|
|Study Completion Date :||December 2014|
Experimental: Azithromycin PO three times weekly
Tablets Azithromycin 500 mg PO three times weekly for three months
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Other Name: AZITRO
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379196
|Principal Investigator:||Hadas Kalish, MD||Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel|