99Tc-MDP for Thyroid-Associated Ophthalmopathy

Thyroid-Associated Ophthalmopathy Clinical Trial

Official title:

A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948191
• Other study ID #: zsyy_nfm2-2017-10
• Status: Completed
• Phase: Phase 4
• Start date: October 16, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2019
• Source: Dalian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• The patient age 18 Years to 76 Years;

• Fewer than 6 months from onset of TAO;

• Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of = 3;

• Moderate to severe TAO;

• No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.

Exclusion Criteria:

• Optic neuropathy, severe orbital appearance and surgical;

• Extra-thyroid disease;

• Pregnant and children;

• Severe impairment of cardiac, hepatic and renal functions;

• Allergies;

• Other contraindications.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid-Associated Ophthalmopathy

Intervention

Drug:
• Methylprednisolone
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
• 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Locations

Country	Name	City	State
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Dalian University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Status at Week 12	This end point main evaluation improvement of clinical activity score and proptosis at week 12. A reduction of the CAS 2 point or more, and reduction of the proptosis 2 mm or more was defined as response.	Week 12
Secondary	Overall Average Continuous Change in CAS From Baseline to Week 24	The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. CAS of 3 point or more on a 7-point scale indicating active thyroid-associated ophthalmopathy.	Baseline to Week 24
Secondary	Overall Average Continuous Change in Proptosis From Baseline to Week 24	Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded with the Hertel exophthalmometer.	Baseline to Week 24
Secondary	Overall Average Change in Diplopia grading From Baseline to Week 24	Diplopia grading included 01/4no:no diplopia; 11/4intermittent: diplopia in primary position of gaze, when tired or when first awakening; 21/4inconstant: diplopia at extremes of gaze; 31/4constant: continuous diplopia in primary or reading position).; Diplopia change in one grade or more at week 24 was regarded as improvement.	Baseline to Week 24
Secondary	Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24	Observation of extra-ocular muscular thickening is observed on Orbital CT. One or more extra-ocular muscle recovery at week 24 was regarded as improvemed.	Baseline to Week 24
Secondary	Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up	The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid associated ophthalmopathy (TAO) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale.The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health). A change of 8 point was defined as improvement.	Baseline to Week 24
Secondary	Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up	Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 50 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.	Baseline to Week 24
Secondary	Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up	Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 50 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.	Baseline to Week 24