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Prednisone Versus Doxycycline in the Treatment of Graves' Orbitopathy

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Associated Opthalmopathies

Intervention: Prednisone+placebo of Doxycycline (Drug); Doxycycline+placebo of Prednisone (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Dan Liang, MD, Study Chair, Affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
Liya Wang, MD, Principal Investigator, Affiliation: Henan Eye Institue, Henan, China
Luosheng Tang, MD, Principal Investigator, Affiliation: The second xiangya hospital of central south university, Hunan, China

Overall contact:
Dan Liang, MD, Phone: 0086-20-87331766, Email: liangd2@mail.sysu.edu.cn

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).

Clinical Details

Official title: The Effect of Prednisone Versus Doxycycline in Active, Moderately Severe Graves' Orbitopathy: A Randomized, Multi-center, Double-blind, Parallel-controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall treatment response

Secondary outcome:

• Health related quality of life questionnaires (GO-QoL)

• Safety and tolerability as assessed by adverse events, vital signs

• Quantitative changes of rectus diameter measured by MRI scan

Relapse

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 until the inflammatory phase has passed. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids are the first-choice immunosuppressive treatment, having a successful outcome of 50-70% in patients. However, long time usage of corticosteroids often cause severe side-effects. Sub-antimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of sub-antimicrobial dose doxycycline for treating inflammatory or autoimmune diseases, such as rosacea, periodontitis and multiple sclerosis. The mechanism is by inhibiting lymphocyte proliferation and production of colony-stimulating factor, inflammatory cytokines, and immunoglobulins, factors thought to play a role in the orbital autoimmune process. These mechanisms make them, in theory, an attractive option of doxycycline for treating Graves' Orbitopathy. In addition, only few adverse events were reported when doxycycline were administered for 3 months in patients with periodontitis or rosacea. We propose to compare the effect and safety of sub-antimicrobial dose doxycycline versus prednisone for treating non-sight threatening, moderate-severe, inflammatory GO.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Dan Liang, MD, Phone: 0086-20-87331766, Email: liangd2@mail.sysu.edu.cn

Peking Union Medical College Hospital, Beijing, Beijing 100730, China; Recruiting
Yong Zhong, MD, Phone: +86-10-69156114, Email: yzhong_eye@yahoo.com.cn

Zhongshan Ophthalmic Center, Guangzhou, Guangdong 510060, China; Recruiting
Dan Liang, MD, Phone: 0086-20-87331766, Email: liangd2@mail.sysu.edu.cn

JOINT SHANTOU INTERNATIONALL EYE CENTER of Shantou University and the Chinese University of Hong Kong, Shantou, Guangdong 515041, China; Recruiting
Mingzhi Zhang, MD, Phone: +86-754-88393501, Email: zmz@jsiec.org

Shenzhen Eye Hospital, Shenzhen, Guangdong 518040, China; Recruiting
Guiqin Liu, MD, Phone: +86-755-23959600, Email: liuguiqin9@yahoo.com.cn

Henan Eye Institue, Henan, China, Zhengzhou, Henan 450003, China; Recruiting
Liya wang, MD, Phone: 0086-13937169191, Email: wangliya55@126.com

The second xiangya hospital of central south university, Changsha, Hunan 410011, China; Recruiting
Wei Xiong, MD, Phone: 0086-138-0846-9035, Email: weixiong420@163.com

Additional Information

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofacioc

MedlinePlus related topics: Antibiotics Eye Diseases Thyroid Diseases

U.S. FDA Resources

Starting date: November 2012
Last updated: December 7, 2013

Page last updated: August 23, 2015

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