Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO

Thyroid Associated Ophthalmopathy Clinical Trial

Official title:

Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04548284
• Other study ID #: yanghs202009
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathy

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