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

NCT ID: NCT04548284

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Thyroid Associated Ophthalmopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Periorbitally Injected 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.

Group Type: EXPERIMENTAL

Glucocorticoids

Intervention Type: DRUG

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.

Observe

Observe and wait.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huasheng Yang

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huasheng Yang, Doctor

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huasheng Yang, M.D, PHD

Role: CONTACT

yanghs64@126.com

+8620-87331539

Huasheng Yang, Doctor

Role: CONTACT

Facility Contacts

Huasheng Yang, M.D, PHD

Role: primary

yanghs64@126.com

+8620-87331539

Other Identifiers

yanghs202009

Identifier Type: -

Identifier Source: org_study_id