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

NCT01379196 | Withdrawn Phase 1 DMC

• 1 other identifier: 0427-10-RMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Graves Ophthalmopathy

Keywords

Graves Orbitopathy; Macrolide antibiotics; Inflammation; Clinical Activity Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measurement of extraocular muscle thickening

  3 months

• ANTI TSH Receptor antibody levels

  0, 3 and 6 months

Study Arms (1)

Azithromycin PO three times weekly

EXPERIMENTAL

Tablets Azithromycin 500 mg PO three times weekly for three months

Drug: Azithromycin

Interventions

Azithromycin DRUG

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

Also known as: AZITRO

Azithromycin PO three times weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Graves Orbitopathy
• Clinical activity score higher than 2
• Must be able to swallow tablets

You may not qualify if:

• sight-threatening Graves Orbitopathy
• Diplopia in primary gaze
• Macrolide allergy or intolerance

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Graves Ophthalmopathy; Inflammation

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Hadas Kalish, MD

  Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Neuro-Ophthalmology Unit

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: June 23, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 27, 2017

Record last verified: 2017-04