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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04548284
Other study ID # yanghs202009
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 2021
Est. completion date December 2023

Study information

Verified date May 2021
Source Sun Yat-sen University
Contact Huasheng Yang, M.D, PHD
Phone +8620-87331539
Email yanghs64@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.


Recruitment information / eligibility

Status Recruiting
Enrollment 142
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: General conditions: 1. clinically diagnosed as thyroid disease; 2. able and willing to participate in clinical trials and ensure regular follow-up. Eye condition: 1. patients with monocular disease diagnosed by TAO; 2. EUGOGO/NOSPECS grade was mild and CAS score was less than 3; 3. the course of eye disease was less than 12mo and had not been treated in the past. Exclusion Criteria: General situation: 1. patients with poor blood glucose control in recent 3 months, glycosylation = 10% ; 2. blood pressure still fluctuated > 180/110mmHg after medication; 3. obvious liver and kidney insufficiency; 4. contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.); 5. patients with severe abnormal blood coagulation; 6. patients with other systemic immune diseases; 7. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors); 8. history of chronic infection; 9. pregnant and lactating women. Eye conditions: 1. B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.); 2. moderate to severe TAO, in either eye requiring local or systemic treatment; 3. periorbital infectious diseases, hemorrhagic diseases; 4. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases. 5. those who studied the eyes who had a history of arbitrary surgery; 6. those who were considered by the researchers to be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Glucocorticoids
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.

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline?3months?6months?9months?12months
Primary 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. baseline?3months?6months?9months?12months
Secondary adverse events Comparison of adverse events rate in each arm and an inter-arm. baseline?3months?6months?9months?12months
Secondary 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. baseline?3months?6months?9months?12months
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