Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO
Primary Purpose
Thyroid Associated Ophthalmopathy
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Glucocorticoids
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Associated Ophthalmopathy
Eligibility Criteria
Inclusion Criteria:
General conditions:
- clinically diagnosed as thyroid disease;
- able and willing to participate in clinical trials and ensure regular follow-up.
Eye condition:
- patients with monocular disease diagnosed by TAO;
- EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
- the course of eye disease was less than 12mo and had not been treated in the past.
Exclusion Criteria:
General situation:
- patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
- blood pressure still fluctuated > 180/110mmHg after medication;
- obvious liver and kidney insufficiency;
- contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
- patients with severe abnormal blood coagulation;
- patients with other systemic immune diseases;
- any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
- history of chronic infection;
- pregnant and lactating women.
Eye conditions:
- B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
- moderate to severe TAO, in either eye requiring local or systemic treatment;
- periorbital infectious diseases, hemorrhagic diseases;
- uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.
- those who studied the eyes who had a history of arbitrary surgery;
- those who were considered by the researchers to be excluded.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Periorbitally Injected Glucocorticoids
Observe
Arm Description
Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
Observe and wait.
Outcomes
Primary Outcome Measures
Change of Clinical Activity Score (CAS) score
Comparison of CAS scores before and after treatment in each arm and an inter-arm. The range of CAS scores is 0-7, with 3 as the boundary. The higher the score, the higher the activity.
Change of NOSPECS score
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. The NOSPECS score was 0-6. The higher the score, the higher the severity.
Secondary Outcome Measures
adverse events
Comparison of adverse events rate in each arm and an inter-arm.
Quality of life questionnaires (GO-QoL)
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm. The GO-QOL score is between 0 and 100. The higher the score, the better the quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04548284
Brief Title
Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO
Official Title
Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
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
The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.
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 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Periorbitally Injected Glucocorticoids
Arm Type
Experimental
Arm Description
Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
Arm Title
Observe
Arm Type
No Intervention
Arm Description
Observe and wait.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Intervention Description
Periorbital injection of glucocorticoid. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
Primary Outcome Measure Information:
Title
Change of Clinical Activity Score (CAS) score
Description
Comparison of CAS scores before and after treatment in each arm and an inter-arm. The range of CAS scores is 0-7, with 3 as the boundary. The higher the score, the higher the activity.
Time Frame
baseline、3months、6months、9months、12months
Title
Change of NOSPECS score
Description
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. The NOSPECS score was 0-6. The higher the score, the higher the severity.
Time Frame
baseline、3months、6months、9months、12months
Secondary Outcome Measure Information:
Title
adverse events
Description
Comparison of adverse events rate in each arm and an inter-arm.
Time Frame
baseline、3months、6months、9months、12months
Title
Quality of life questionnaires (GO-QoL)
Description
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm. The GO-QOL score is between 0 and 100. The higher the score, the better the quality of life.
Time Frame
baseline、3months、6months、9months、12months
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:
General conditions:
clinically diagnosed as thyroid disease;
able and willing to participate in clinical trials and ensure regular follow-up.
Eye condition:
patients with monocular disease diagnosed by TAO;
EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
the course of eye disease was less than 12mo and had not been treated in the past.
Exclusion Criteria:
General situation:
patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
blood pressure still fluctuated > 180/110mmHg after medication;
obvious liver and kidney insufficiency;
contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
patients with severe abnormal blood coagulation;
patients with other systemic immune diseases;
any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
history of chronic infection;
pregnant and lactating women.
Eye conditions:
B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
moderate to severe TAO, in either eye requiring local or systemic treatment;
periorbital infectious diseases, hemorrhagic diseases;
uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.
those who studied the eyes who had a history of arbitrary surgery;
those who were considered by the researchers to be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huasheng Yang, Doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, Doctor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO
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