CClinicalTrials.gg
Sign In
Status unknownNCT04548284Updated May 18, 2021

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

A Phase 3 interventional study of Glucocorticoids in Thyroid Associated Ophthalmopathy, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-18.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Thyroid Associated Ophthalmopathy
03

In context

Eye Diseases

740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.

This study's planned enrollment of 142 is above the median of 68 across 547 interventional studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
142 participants (estimated)

Study arms

  • 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

  • No intervention
    Observe

    Observe and wait.

Interventions

  • DrugGlucocorticoids

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline、3months、6months、9months、12months

  2. 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.

    Time frame: baseline、3months、6months、9months、12months

Secondary outcomes

  1. adverse events

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

    Time frame: baseline、3months、6months、9months、12months

  2. 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.

    Time frame: baseline、3months、6months、9months、12months

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04548284
Lead sponsor
Sun Yat-sen University
Responsible party
Huasheng Yang (Principal Investigator, Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Sep 14, 2020
Start date
May 2021 (estimated)
Primary completion
Jun 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
May 18, 2021

Study contacts

Huasheng Yang, M.D, PHD
Contact
yanghs64@126.com
+8620-87331539
Huasheng Yang, Doctor
Contact
Huasheng Yang, Doctor
study chair · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Eye Diseases→

Other studies from this sponsor

Sun Yat-sen University

Start the discussion