Status:
UNKNOWN
Prednisone Versus Doxycycline in the Treatment of Graves' Orbitopathy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Thyroid Associated Opthalmopathies
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to compare the efficacy and safety of prednisone versus sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe Graves' Orbitopathy (GO).
Detailed Description
Graves' orbitopathy is an autoimmune disease characterized by an inflammatory phase followed by fibrosis. Surgery to correct eyelid swelling, proptosis, and diplopia is effective, but can not be done ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Graves' Orbitopathy (as defined by Bartley and Gorman)
- Eyelid retraction (upper eyelid margin at or above the superior corneoscleral limbus in primary gaze without frontalis muscle contraction) in association with any one of the following:
- Thyroid dysfunction or abnormal regulation (increased serum thyroxine or triiodothyronine level, decreased serum thyroid stimulating hormone level, absence of thyroid radioiodine uptake suppression after administration of triiodothyronine, or the presence of thyroid stimulating immunoglobulins in serum)
- Exophthalmos
- Extraocular muscle involvement (restrictive myopathy or objective evidence of enlarged muscles)
- Optic nerve dysfunction (abnormal visual acuity, color vision, pupillary reaction or perimetry not attributable to other causes) OR
- Thyroid dysfunction or abnormal regulation in association with any one of the following:
- Exophthalmos
- Extraocular muscle involvement
- Optic nerve dysfunction
- Moderate-severe GO According to EUGOGO statement, patients with moderate-severe GO usually have any one or more of the following：lid retraction≥2mm, moderate or severe soft tissue involvement, exophthalmos≥3mm above normal for race and gender, inconstant, or constant diplopia.
- Clinical activity score ≥ 3
- Being euthyroid for at least 1 months before the date of inclusion
- Must be able to swallow tablets
- Written informed consent is obtained
Exclusion
- Mild Graves' Orbitopathy
- Sight-threatening Graves' Orbitopathy
- Clinical activity score \< 3
- Previous treatment for GO Oral steroids, intravenous steroids, radiotherapy
- Pregnant females as determined by positive (serum or urine) human chorionic gonadotrophin (hCG) test at screening or prior to dosing, or lactating females
- Uncontrolled diabetes or hypertension
- History of mental / psychiatric disorder
- Hepatic dysfunction (Albumin (Alb) , Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility)
- Renal impairment (Urea and Creatinine levels must be within normal range)
- Doxycycline or Prednisone allergy or intolerance
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01809444
Start Date
November 1 2012
End Date
January 1 2016
Last Update
December 10 2013
Active Locations (6)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
2
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060
3
JOINT SHANTOU INTERNATIONALL EYE CENTER of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China, 515041
4
Shenzhen Eye Hospital
Shenzhen, Guangdong, China, 518040