99Tc-MDP for Thyroid-Associated Ophthalmopathy

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dalian University
• Treatments: Methylene diphosphonate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Technetium Tc 99m Medronate

Criteria

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.