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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:
ClinicalTrials.gov Identifier:
NCT00954057
First Posted: August 6, 2009
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neothetics, Inc
  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
Intervention Model: Parallel Assignment
Masking: Single (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954057


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

Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT00954057     History of Changes
Other Study ID Numbers: LIPO-102-CL-06
First Submitted: August 4, 2009
First Posted: August 6, 2009
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Neothetics, Inc:
TED

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