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

Phase 3

• Conditions: Thyroid Associated Ophthalmopathy
• Interventions: Drug: Glucocorticoids

• Registration Number: NCT04548284
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Status Verified: 2021-05
• Study Start: 2021-05
• Last Update Submitted: 2021-05-15
• Last Update Posted: 2021-05-18
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periorbitally Injected Glucocorticoids	Glucocorticoids	Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.

Primary Outcome Measures

Name	Time	Method
Change of Clinical Activity Score (CAS) score	baseline、3months、6months、9months、12months	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	baseline、3months、6months、9months、12months	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

Name	Time	Method
Quality of life questionnaires (GO-QoL)	baseline、3months、6months、9months、12months	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.
adverse events	baseline、3months、6months、9months、12months	Comparison of adverse events rate in each arm and an inter-arm.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China