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SAfe immunomodulation reserVEd for Mild-to-mOderate, REcent-onset TED (SAVE-MORE-TED) - a multi-center, randomized, double-masked, placebo-controlled trial

SAfe immunomodulation reserVEd for Mild-to-mOderate, REcent-onset TED (SAVE-MORE-TED) - a multi-center, randomized, double-masked, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102865
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Treatment Group 1 :Selenium 200ug (1 tab) daily
Treatment Group 2:Atorvastatin 20mg (1 tab) daily
Treatment Group 3:Doxycycline 50mg (1 tab) daily
Treatment Group 4:Hydroxychloroquine 200mg (1 tab) daily
Treatment Group 5:Vitamin D 2800 IU (1 tab) daily
Control Group:Placebo (1 tab) daily

Sponsors

The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. TED with mild severity (at least 1 sign) as defined by EUGOGO in the most affected eye: (1) Mild lid retraction of either upper or lower eyelid (marginal reflex distance 1 or 2 between 5 to 7mm) (2) Mild soft-tissue involvement (NOSPECS class 2a and 2b) (3) Exophthalmos 3/7

Exclusion criteria

Exclusion criteria: 1. Age 80 yrs. 2. Compressive optic neuropathy by EUGOGO criteria 3. Exophthalmos>22mm 4. Diplopia in primary or reading position, and/ or ocular torticollis 5. Monocular duction in any direction of 3 times the upper normal range. 19. Severe familial hyperlipidaemia or presence of more than one associated cardiovascular risk factor (diabetes, high blood pressure, smoking, familial history of acute cardiovascular events, obesity), medically indicated for cholesterol-lowering medications.

Design outcomes

Primary

MeasureTime frame
Proportion achieving excellent-to-good versus similar-or-worse CTS at month 6 (response) and 12 (recurrence).;

Secondary

MeasureTime frame
Serial comparisons of CTS, orbital, psychosocial, serological parameters among groups;Proportion of patients requiring additional treatments for TED;Complications;Therapeutic responses;Factors associated with compliance;

Countries

China

Contacts

Public ContactKam Lung Chong

The Chinese University of Hong Kong

chongkamlung@cuhk.edu.hk+852 3943 5805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026