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)

Phase 2

Completed

• Conditions: Thyroid-Related Eye Disease
• Interventions: Drug: LIPO-102; Drug: Placebo

• Registration Number: NCT00954057
• Lead Sponsor: Neothetics, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2009-09
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-03
• Disposition First Submitted: 2015-03-05
• Disposition First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Disposition First Posted: 2015-03-26
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIPO-102	LIPO-102	Intraorbital Injection
Placebo	Placebo	Intraorbital Injection

Primary Outcome Measures

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

Secondary Outcome Measures

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