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

Graves Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01379196
• Other study ID #: 0427-10-RMC
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 11, 2011
• Last updated: April 25, 2017
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Intervention

Drug:
• Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three months
Secondary	Measurement of extraocular muscle thickening	Ultrasonic measurement of extraocular muscle thickening	3 months
Secondary	ANTI TSH Receptor antibody levels	Serum measurements of ANTI TSH Receptor antibody levels	0, 3 and 6 months