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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University
      • Sub-Investigator: Shen Jie

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:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Ia; 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.	Drug: Glucocorticoids; Intravenous Glucocorticoids (GCs); Other Names: Methylprednisolone
Experimental: Group Ib; 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.	Drug: Glucocorticoids; Intravenous Glucocorticoids (GCs); Other Names: Methylprednisolone
Experimental: Group IIa; 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.	Drug: Glucocorticoids; Intravenous Glucocorticoids (GCs); Other Names: Methylprednisolone
Experimental: Group IIb; 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.	Drug: Glucocorticoids; Intravenous Glucocorticoids (GCs); Other Names: Methylprednisolone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jie Shen
• Collaborators: Zhujiang Hospital; The Fifth Affiliated Hospital of Southern Medical University; Huadu District People's Hospital of Guangzhou

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 16, 2017
• Last Verified: April 1, 2017

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; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Methylprednisolone; Glucocorticoids
• Other Study ID Numbers: ThirdAffiliatedHospitalOfSMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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