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

Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Associated Ophthalmopathy
• Intervention / Treatment: Drug: Glucocorticoids

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Huasheng Yang, M.D, PHD; Phone Number: +8620-87331539; Email: yanghs64@126.com
• Study Contact Backup: Name: Huasheng Yang, Doctor

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Huasheng Yang, M.D, PHD; Phone Number: +8620-87331539; Email: yanghs64@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Comparison of adverse events rate in each arm and an inter-arm.	baseline、3months、6months、9months、12months
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucocorticoids
• Other Study ID Numbers: yanghs202009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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