99Tc-MDP for Thyroid-Associated Ophthalmopathy
- Conditions
- Thyroid-Associated Ophthalmopathy
- Interventions
- Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
- Registration Number
- NCT03948191
- Lead Sponsor
- Dalian University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- Optic neuropathy, severe orbital appearance and surgical;
- Extra-thyroid disease;
- Pregnant and children;
- Severe impairment of cardiac, hepatic and renal functions;
- Allergies;
- Other contraindications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 99Tc-MDP 99Tc-MDP(99Technetium-Methylenediphosphonate Injection) 99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions. Methylprednisolone(ivMP) Methylprednisolone Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
- Primary Outcome Measures
Name Time Method Responder Status at Week 12 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 Outcome Measures
Name Time Method Overall Average Continuous Change in CAS From Baseline to Week 24 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.
Overall Average Continuous Change in Proptosis From Baseline to Week 24 Baseline to Week 24 Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded with the Hertel exophthalmometer.
Overall Average Change in Diplopia grading From Baseline to Week 24 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.Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24 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.
Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up 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.
Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up 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.
Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up 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.
Trial Locations
- Locations (1)
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China