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Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy

NCT ID: NCT02203682

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2022-07-31

Brief Summary

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The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Thyroid-Associated Ophthalmopathy (TAO).

Detailed Description

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Thyroid-Associated Ophthalmopathy is an autoimmune disease that can be treated by corticosteroids and surgery. But they often cause severe side-effects and are usually used for treating moderate-sever and sight-threatening TAO. Wait and see will be the first choice for the patient with mild TAO.

Subantimicrobial dose (SD) doxycycline displays a strong anti-inflammatory and immunomodulatory function, which is independent of its antibiotic properties. Data from clinical trials demonstrated that SD doxycycline was effective in moderating inflammation in a variety of autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, rosacea and periodontitis.

We propose to test the effect of subantimicrobial dose doxycycline for mild TAO.

Conditions

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Graves Ophthalmopathy Graves Disease Thyroid-associated Ophthalmopathy Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Hyperthyroidism Autoimmune Diseases Immune System Diseases

Keywords

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Graves' orbitopathy Graves´ ophthalmopathy Thyroid eye disease Thyroid-associated ophthalmopathy Doxycycline EUGOGO CAS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Doxycycline

Tablets Doxycycline 50 mg PO per day for 12 weeks

Group Type EXPERIMENTAL

Doxycycline hyclate

Intervention Type DRUG

Tab. Doxycycline 50 mg PO per day for 12 weeks

Placebo

Tablet placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet placebo for 12 weeks

Interventions

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Doxycycline hyclate

Tab. Doxycycline 50 mg PO per day for 12 weeks

Intervention Type DRUG

Placebo

Tablet placebo for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Thyroid-associated ophthalmopathy
* Mild TAO
* Normal serum free thyroxine and free triiodothyronine concentrations
* No previous specific therapy for TAO, except for local measures
* Written informed consent is obtained

Exclusion Criteria

* Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing, or lactating females
* Uncontrolled diabetes or hypertension
* History of mental / psychiatric disorder
* Hepatic dysfunction (Alb, AST, ALT and Alkaline phosphates levels must be within normal range for eligibility)
* Renal impairment (Urea and Creatinine levels must be within normal range)
* Tetracycline allergy or intolerance
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Dan Liang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongsh Ophthalmic Center

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Liang, MD

Role: CONTACT

Phone: 0086-20-87331766

Email: [email protected]

Facility Contacts

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Dan Liang, MD

Role: primary

References

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Pan Y, Chen YX, Zhang J, Lin ML, Liu GM, Xu XL, Fan XQ, Zhong Y, Li Q, Ai SM, Xu W, Tan J, Zhou HF, Xu DD, Zhang HY, Xu B, Wang S, Ma JJ, Zhang S, Gan LY, Cui JT, Li L, Xie YY, Guo X, Pan-Doh N, Zhu ZT, Lu Y, Shi YX, Xia YW, Li ZY, Liang D. Doxycycline vs Placebo at 12 Weeks in Patients With Mild Thyroid-Associated Ophthalmopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Nov 1;140(11):1076-1083. doi: 10.1001/jamaophthalmol.2022.3779.

Reference Type DERIVED
PMID: 36173609 (View on PubMed)

Other Identifiers

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2013MEKY033

Identifier Type: -

Identifier Source: org_study_id