A phase III, randomized, controlled, open label, no profit, single-center intervention study to compare the effect of a conservative (antithyroid drugs) and an ablative approach (radioiodine or total thyroidectomy) for the treatment of hyperthyroidism in patients with Graves’ disease and moderate-to-severe and active Graves’ Orbitopathy (GO) treated with intravenous glucocorticoids (ABLAGO Study)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518452-23-00

Enrollment

Registered

2024-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-19

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

Conditions

Graves' disease and Graves' orbitophaty

Brief summary

Response rate 24 weeks after inclusion: -Comparison of overall GO outcome determined using a composite evaluation as indicated below. The evaluation will be performed by a unblinded ophthalmologist and will be documented in the CRF, including the following items: -Lid aperture in mm - CAS (5 items) -Exophthalmos in mm using a Hertel exophthalmometer -Eye ductions -Visual acuity using the Snellen chart in log10

Interventions

DRUGSodio ioduro (I131) Curium Netherlands 37-7400 MBq capsula rigida

DRUGTAPAZOLE 5 mg compresse

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Response rate 24 weeks after inclusion: -Comparison of overall GO outcome determined using a composite evaluation as indicated below. The evaluation will be performed by a unblinded ophthalmologist and will be documented in the CRF, including the following items: -Lid aperture in mm - CAS (5 items) -Exophthalmos in mm using a Hertel exophthalmometer -Eye ductions -Visual acuity using the Snellen chart in log10	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026