NCT03098225View on ClinicalTrials.gov

A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2027

Conditions
Thyroid Associated Ophthalmopathy
Interventions
RADIATION

Orbital radiotherapy

A high-voltage linear accelerator will be used and a cumulative radiation dose of 20 Gy will be delivered to each eye in 10 fractionated doses over a period of 2 weeks. All patients will be treated in both eyes.

DRUG

Methylprednisolone

Methylprednisolone pulse therapy for 12 weeks as follows: 500 mg IV once weekly for 6 weeks, then 250 mg IV once weekly for a further 6 weeks. Cumulative dose 4.5 g.

All Listed Sponsors
lead

University of Pisa

OTHER