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)

This study is not yet open for participant recruitment.

Verified by Lithera, Inc, August 2009

First Received: August 4, 2009 Last Updated: August 5, 2009 History of Changes

Sponsored by:	Lithera, Inc
Information provided by:	Lithera, Inc
ClinicalTrials.gov Identifier:	NCT00954057

Purpose

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

Condition	Intervention	Phase
Thyroid-Related Eye Disease	Drug: LIPO-102 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Thyroid

Further study details as provided by Lithera, Inc:

Primary Outcome Measures:

Safety: physical examinations, laboratory tests, VISA activity score, AE assessments [ Time Frame: 8 weeks treatment and 1 week follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction [ Time Frame: 8 weeks treatment and 1 week follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LIPO-102: Experimental Intraorbital Injection	Drug: LIPO-102 intraorbital injection
Placebo: Placebo Comparator Intraorbital Injection	Drug: Placebo intraorbital injection

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954057

Contacts

Contact: Trinh Le

858 750-1008

Locations

Sponsors and Collaborators

Lithera, Inc

More Information

No publications provided

Responsible Party:	Lithera, Inc. ( Vice President, Regulatory Affairs and Quality )
Study ID Numbers:	LIPO-102-CL-06
Study First Received:	August 4, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00954057 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lithera, Inc:

TED

Study placed in the following topic categories:

Eye Diseases
Orbital Diseases
Exophthalmos

Additional relevant MeSH terms:

Eye Diseases
Orbital Diseases
Exophthalmos

ClinicalTrials.gov processed this record on September 11, 2009