Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Primary Purpose
Graves Ophthalmopathy
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Graves Ophthalmopathy focused on measuring Graves Orbitopathy, Macrolide antibiotics, Inflammation, Clinical Activity Score
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Azithromycin PO three times weekly
Arm Description
Tablets Azithromycin 500 mg PO three times weekly for three months
Outcomes
Primary Outcome Measures
Change in clinical activity score between baseline and after 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
Measurement of extraocular muscle thickening
Ultrasonic measurement of extraocular muscle thickening
ANTI TSH Receptor antibody levels
Serum measurements of ANTI TSH Receptor antibody levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01379196
Brief Title
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Official Title
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Patients were not interested in enrolling
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Ophthalmopathy
Keywords
Graves Orbitopathy, Macrolide antibiotics, Inflammation, Clinical Activity Score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin PO three times weekly
Arm Type
Experimental
Arm Description
Tablets Azithromycin 500 mg PO three times weekly for three months
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
AZITRO
Intervention Description
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Primary Outcome Measure Information:
Title
Change in clinical activity score between baseline and after three months
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Measurement of extraocular muscle thickening
Description
Ultrasonic measurement of extraocular muscle thickening
Time Frame
3 months
Title
ANTI TSH Receptor antibody levels
Description
Serum measurements of ANTI TSH Receptor antibody levels
Time Frame
0, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadas Kalish, MD
Organizational Affiliation
Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
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