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

NCT04548284 | Unknown Phase 3 DMC

• 1 other identifier: yanghs202009
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• adverse events

  baseline、3months、6months、9months、12months

• Quality of life questionnaires (GO-QoL)

  baseline、3months、6months、9months、12months

Study Arms (2)

Periorbitally Injected Glucocorticoids

EXPERIMENTAL

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

Observe

NO INTERVENTION

Observe and wait.

Interventions

Glucocorticoids 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.

Periorbitally Injected Glucocorticoids

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General conditions:
• clinically diagnosed as thyroid disease;
• able and willing to participate in clinical trials and ensure regular follow-up.
• Eye condition:
• patients with monocular disease diagnosed by TAO;
• EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
• the course of eye disease was less than 12mo and had not been treated in the past.

You may not qualify if:

• General situation:
• patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
• blood pressure still fluctuated \> 180/110mmHg after medication;
• obvious liver and kidney insufficiency;
• contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
• patients with severe abnormal blood coagulation;
• patients with other systemic immune diseases;
• any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
• history of chronic infection;
• pregnant and lactating women.
• Eye conditions:
• B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
• moderate to severe TAO, in either eye requiring local or systemic treatment;
• periorbital infectious diseases, hemorrhagic diseases;
• uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Huasheng Yang, Doctor

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Huasheng Yang, M.D, PHD

CONTACT

+8620-87331539; yanghs64@126.com

Huasheng Yang, Doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: May 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

CN (1)