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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.
Information provided by (Responsible Party):
Neothetics, Inc Identifier:
First received: August 4, 2009
Last updated: March 5, 2015
Last verified: March 2015
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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:

Further study details as provided by Neothetics, Inc:

Primary Outcome Measures:
  • Safety: physical examinations, laboratory tests, VISA activity score, AE assessments [ Time Frame: 8 weeks treatment and 1 week follow up ]

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 ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00954057

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

Responsible Party: Neothetics, Inc Identifier: NCT00954057     History of Changes
Other Study ID Numbers: LIPO-102-CL-06
Study First Received: August 4, 2009
Last Updated: March 5, 2015

Keywords provided by Neothetics, Inc:

Additional relevant MeSH terms:
Thyroid Diseases
Eye Diseases
Endocrine System Diseases
Orbital Diseases processed this record on April 28, 2017