Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial

Phase 4

• Conditions: Thyroid Associated Ophthalmopathy
• Interventions: Drug: Glucocorticoids

• Registration Number: NCT03107078
• Lead Sponsor: Jie Shen

Brief Summary

For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.

Detailed Description

TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-03-08
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Last Update Submitted: 2017-04-16
• Last Update Posted: 2017-04-18
• Primary Completion: 2019-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. The diagnostic standard of TAO is according to Bartley's criteria.
2. Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
3. CAS≥3/7.
4. None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.

Exclusion Criteria

1. NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
2. Suffering from other eye diseases or wearing contact lenses.
3. Suffering from other autoimmune diseases.
4. Acute and chronic infectious diseases.
5. Diabetic retinopathy or hypertensive fundus lesions.
6. Patients received orbital decompression or other orbital surgery.
7. Suffering from eye trauma or ocular surface disease.
8. Special occupants, and the working environment has obvious air pollution etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Ib	Glucocorticoids	I:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.
Group Ia	Glucocorticoids	I:The increase of fat volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.
Group IIa	Glucocorticoids	II:The increase of extraocular muscles volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.
Group IIb	Glucocorticoids	II:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.

Primary Outcome Measures

Name	Time	Method
Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment	2years	"Response" was defined as at least three of the following outcome measures: 1. reduction in lid width by at least 3 mm; 2. reduction in any of the class 2 NOSPECS signs by at least two grades; 3. reduction in proptosis by at least 2 mm; 4. reduction in intraocular pressure by at least 2 mm Hg; 5. improvement in CAS by at least two points; 6. improvement in diplopia (disappearance or degrade in degree); 7. improvement in visual acuity by 1 Snellen line.
Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment	2years	"Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.
Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment	2years	"Deterioration" of each parameter was defined as follows: 1. increase in lid width by at least 3 mm; 2. increase in any of the class 2 NOSPECS signs by at least two grades; 3. increase in proptosis by at least 2 mm; 4. increase in intraocular pressure by at least 2 mm Hg; 5. increase in CAS by at least two points; 6. increase in diplopia (new onset or upgrade in degree); 7. decrease in visual acuity by 1 Snellen line.

Trial Locations

Locations (1)

the Third Affiliated Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China