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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 has been completed.
Sponsor:
Information provided by:
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT00954057
First received: August 4, 2009
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:

Drug Information available for: Thyroid
U.S. FDA Resources

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 ]

Enrollment: 11
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102
Intraorbital Injection
 Drug: LIPO-102
intraorbital injection
Placebo Comparator: Placebo
Intraorbital Injection
 Drug: Placebo
intraorbital injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
Australia
Adelaide, Australia
Brisbane, Australia
Melbourne, Australia
Sydney, Australia
New Zealand
Auckland, New Zealand
Sponsors and Collaborators
Lithera, Inc
  More Information

No publications provided

Responsible Party: Vice President, Regulatory Affairs and Quality, Lithera, Inc.
ClinicalTrials.gov Identifier: NCT00954057     History of Changes
Other Study ID Numbers: LIPO-102-CL-06
Study First Received: August 4, 2009
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
New Zealand: Ministry of Health

Keywords provided by Lithera, Inc:
TED

Additional relevant MeSH terms:
Exophthalmos
Eye Diseases
Thyroid Diseases
Orbital Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013