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Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial

Primary Purpose

Thyroid Associated Ophthalmopathy

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glucocorticoids
Sponsored by
Jie Shen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Associated Ophthalmopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The diagnostic standard of TAO is according to Bartley's criteria.
  2. Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
  3. CAS≥3/7.
  4. None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.

Exclusion Criteria:

  1. NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
  2. Suffering from other eye diseases or wearing contact lenses.
  3. Suffering from other autoimmune diseases.
  4. Acute and chronic infectious diseases.
  5. Diabetic retinopathy or hypertensive fundus lesions.
  6. Patients received orbital decompression or other orbital surgery.
  7. Suffering from eye trauma or ocular surface disease.
  8. Special occupants, and the working environment has obvious air pollution etc.

Sites / Locations

  • the Third Affiliated Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group Ia

Group Ib

Group IIa

Group IIb

Arm Description

I:The increase of fat volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.

I:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.

II:The increase of extraocular muscles volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.

II:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.

Outcomes

Primary Outcome Measures

Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
"Response" was defined as at least three of the following outcome measures: reduction in lid width by at least 3 mm; reduction in any of the class 2 NOSPECS signs by at least two grades; reduction in proptosis by at least 2 mm; reduction in intraocular pressure by at least 2 mm Hg; improvement in CAS by at least two points; improvement in diplopia (disappearance or degrade in degree); improvement in visual acuity by 1 Snellen line.
Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
"Deterioration" of each parameter was defined as follows: increase in lid width by at least 3 mm; increase in any of the class 2 NOSPECS signs by at least two grades; increase in proptosis by at least 2 mm; increase in intraocular pressure by at least 2 mm Hg; increase in CAS by at least two points; increase in diplopia (new onset or upgrade in degree); decrease in visual acuity by 1 Snellen line.
Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
"Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2017
Last Updated
April 16, 2017
Sponsor
Jie Shen
Collaborators
The Fifth Affiliated Hospital of Southern Medical University, Huadu District People's Hospital of Guangzhou, Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03107078
Brief Title
Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
Official Title
Using A Novel Classification System in Intravenous Glucocorticoids Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Shen
Collaborators
The Fifth Affiliated Hospital of Southern Medical University, Huadu District People's Hospital of Guangzhou, Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.
Detailed Description
TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Ophthalmopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Ia
Arm Type
Experimental
Arm Description
I:The increase of fat volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.
Arm Title
Group Ib
Arm Type
Experimental
Arm Description
I:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.
Arm Title
Group IIa
Arm Type
Experimental
Arm Description
II:The increase of extraocular muscles volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.
Arm Title
Group IIb
Arm Type
Experimental
Arm Description
II:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Other Intervention Name(s)
Methylprednisolone
Intervention Description
Intravenous Glucocorticoids (GCs)
Primary Outcome Measure Information:
Title
Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
Description
"Response" was defined as at least three of the following outcome measures: reduction in lid width by at least 3 mm; reduction in any of the class 2 NOSPECS signs by at least two grades; reduction in proptosis by at least 2 mm; reduction in intraocular pressure by at least 2 mm Hg; improvement in CAS by at least two points; improvement in diplopia (disappearance or degrade in degree); improvement in visual acuity by 1 Snellen line.
Time Frame
2years
Title
Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
Description
"Deterioration" of each parameter was defined as follows: increase in lid width by at least 3 mm; increase in any of the class 2 NOSPECS signs by at least two grades; increase in proptosis by at least 2 mm; increase in intraocular pressure by at least 2 mm Hg; increase in CAS by at least two points; increase in diplopia (new onset or upgrade in degree); decrease in visual acuity by 1 Snellen line.
Time Frame
2years
Title
Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
Description
"Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnostic standard of TAO is according to Bartley's criteria. Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines. CAS≥3/7. None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months. Exclusion Criteria: NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy). Suffering from other eye diseases or wearing contact lenses. Suffering from other autoimmune diseases. Acute and chronic infectious diseases. Diabetic retinopathy or hypertensive fundus lesions. Patients received orbital decompression or other orbital surgery. Suffering from eye trauma or ocular surface disease. Special occupants, and the working environment has obvious air pollution etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Shen, Doctor
Phone
13808893818
Email
shenjiedr@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangfang Li, Master
Phone
13427525514
Email
leecandy520@163.com
Facility Information:
Facility Name
the Third Affiliated Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang qun
Phone
020-62784060
Email
Zq1979@smu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shen Jie

12. IPD Sharing Statement

Plan to Share IPD
No

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Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial

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