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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04548284
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 4.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Associated Ophthalmopathy	Drug: Glucocorticoids	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study
• Anticipated Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Observe Observe and wait.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. adverse events [baseline、3months、6months、9months、12months]

   Comparison of adverse events rate in each arm and an inter-arm.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Study Chair: Huasheng Yang, Doctor, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huasheng Yang, Principal Investigator, Clinical Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT04548284
• Other Study ID Numbers: yanghs202009
• First Posted: Sep 14, 2020
• Last Update Posted: May 18, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Eye Diseases; Graves Ophthalmopathy; Glucocorticoids

Study Results

No Results Posted as of May 18, 2021