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

Jie Shen

Status and phase: Unknown; Phase 4

Conditions: Thyroid Associated Ophthalmopathy

Treatments: Drug: Glucocorticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT03107078

ThirdAffiliatedHospitalOfSMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Group Ia

Experimental group

Description:

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.

Treatment:

Drug: Glucocorticoids

Group Ib

Experimental group

Description:

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.

Treatment:

Drug: Glucocorticoids

Group IIa

Experimental group

Description:

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.

Treatment:

Drug: Glucocorticoids

Group IIb

Experimental group

Description:

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.

Treatment:

Drug: Glucocorticoids