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)
March 5, 2015 updated by: Neothetics, Inc
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
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia
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Brisbane, Australia
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Melbourne, Australia
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Sydney, Australia
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Auckland, New Zealand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LIPO-102
Intraorbital Injection
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intraorbital injection
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Placebo Comparator: Placebo
Intraorbital Injection
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intraorbital injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Time Frame: 8 weeks treatment and 1 week follow up
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8 weeks treatment and 1 week follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
Time Frame: 8 weeks treatment and 1 week follow up
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8 weeks treatment and 1 week follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
August 4, 2009
First Submitted That Met QC Criteria
August 5, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
March 26, 2015
Last Update Submitted That Met QC Criteria
March 5, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIPO-102-CL-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.