Skip to main content
OpenTrials
Completed

NCT Number: NCT03948191

99Tc-MDP for Thyroid-Associated Ophthalmopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroid-Associated Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylprednisolone

Drug

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)

Drug

15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Other names: Yunke

Primary outcomes

  1. Responder Status at Week 12

    Time frame: 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.

Secondary outcomes

  1. Overall Average Continuous Change in CAS From Baseline to Week 24

    Time frame: 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.

  2. Overall Average Continuous Change in Proptosis From Baseline to Week 24

    Time frame: Baseline to Week 24

    Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded with the Hertel exophthalmometer.

  3. Overall Average Change in Diplopia grading From Baseline to Week 24

    Time frame: 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.

  4. Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24

    Time frame: Baseline 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.

  5. Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up

    Time frame: Baseline to Week 24

    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.

  6. Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up

    Time frame: Baseline to Week 24

    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.

  7. Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up

    Time frame: Baseline to Week 24

    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.

Sponsors and collaborators

Lead sponsor

Dalian University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 13, 2019
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.