Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

What Was Tested

The trial (phase 2) is built around Lanreotide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 5 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with autoimmune thyroid disease and whose centre's medical records confirm the presence of euthyroidism for at least two months before being included into the study.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: the patient presents compressive optical neuropathy signs which require immediate surgical treatment or suffers from serious intensity thyroid ophthalmopathy; the patient has been treated with radio-iodine for his/her thyroid disturbance in the past 6 months; the patient is a smoker of more than 5 cigarettes per day.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Lanreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Lanreotide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Lanreotide.

It started in 2006-01 with completion listed for 2007-04.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Extraocular muscle infiltration and edema exam by evaluating (at Day 0 and Weeks 4, 8 and 12): extraocular muscle size, proptosis and intraocular pressure (tonometry). Eye inspection (at Day 0 and Weeks 4, 8 and 12): assessment of conjunctival injection presence, chemosis, cheratitis and eyelid edema; extrinsic muscle function evaluation and eyelid retraction.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Lanreotide in 5 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, all human trials.