NCT02203682

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 17, 2021

Status Verified

October 1, 2021

Enrollment Period

8 years

First QC Date

July 28, 2014

Last Update Submit

November 16, 2021

Conditions

Graves OphthalmopathyGraves DiseaseThyroid-associated OphthalmopathyThyroid DiseasesEndocrine System DiseasesEye Diseases, HereditaryHyperthyroidismAutoimmune DiseasesImmune System Diseases

Keywords

Graves' orbitopathyGraves´ ophthalmopathyThyroid eye diseaseThyroid-associated ophthalmopathyDoxycyclineEUGOGOCAS

Outcome Measures

Primary Outcomes (1)

  • the rate of improvement

    Improvement was defined that at least one item was met in the study eye without deterioration in any item of both eyes: 1. reduction of eyelid aperture by at least 2mm; 2. reduction in exophthalmos by at least 2mm; 3. increase in ocular motility by at least 8 degrees in any duction; 4. increase on either GO-QOL scales by at least 6 points. The higher of the rate of improvement gets, the better the outcome is. The primary outcome ranges from -100% to 100%.

    12 weeks

Secondary Outcomes (9)

  • Clinical Activity Score (CAS)

    4weeks and 12 weeks

  • Proptosis measured by Hertel instrument

    4weeks and 12 weeks

  • Eyelid aperture

    4weeks and 12 weeks

  • Lid retraction

    4weeks and 12 weeks

  • Lid lag

    4weeks and 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Doxycycline

EXPERIMENTAL

Tablets Doxycycline 50 mg PO per day for 12 weeks

Drug: Doxycycline hyclate

Placebo

PLACEBO COMPARATOR

Tablet placebo for 12 weeks

Drug: Placebo

Interventions

Doxycycline hyclateDRUG

Tab. Doxycycline 50 mg PO per day for 12 weeks

Doxycycline
PlaceboDRUG

Tablet placebo for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36173609DERIVED

MeSH Terms

Conditions

Graves OphthalmopathyGraves DiseaseThyroid DiseasesEndocrine System DiseasesEye Diseases, HereditaryHyperthyroidismAutoimmune DiseasesImmune System Diseases

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Eye DiseasesExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiter

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Dan Liang, MD

    Zhongsh Ophthalmic Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Liang, MD

CONTACT

0086-20-87331766linml0754@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

November 17, 2021

Record last verified: 2021-10

Locations

CN(1)