Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)

A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954057

Enrollment

Registered

2009-08-06

Start date

2009-09-30

Completion date

2011-06-30

Last updated

2015-03-26

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

Conditions

Thyroid-Related Eye Disease

Keywords

TED

Brief summary

This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.

Interventions

DRUGLIPO-102

intraorbital injection

DRUGPlacebo

intraorbital injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or Non pregnant female * Symptomatic exophthalmos * Inactive Thyroid Eye Disease * Signed informed consent

Exclusion criteria

* Known hypersensitivity to study drugs * Treatment with an investigational agent within 30 days of first dose * History of Thyroid Eye Disease less than 6 months * Previous decompression surgery * Glaucoma

Design outcomes

Primary

Measure	Time frame
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments	8 weeks treatment and 1 week follow up

Secondary

Measure	Time frame
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction	8 weeks treatment and 1 week follow up

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026