Back to resultsPilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)
Primary Purpose
Thyroid-Related Eye Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LIPO-102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid-Related Eye Disease focused on measuring TED
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LIPO-102
Placebo
Arm Description
Intraorbital Injection
Intraorbital Injection
Outcomes
Primary Outcome Measures
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Secondary Outcome Measures
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00954057
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neothetics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid-Related Eye Disease
Keywords
TED
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIPO-102
Arm Type
Experimental
Arm Description
Intraorbital Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intraorbital Injection
Intervention Type
Drug
Intervention Name(s)
LIPO-102
Intervention Description
intraorbital injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intraorbital injection
Primary Outcome Measure Information:
Title
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Time Frame
8 weeks treatment and 1 week follow up
Secondary Outcome Measure Information:
Title
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
Time Frame
8 weeks treatment and 1 week follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Adelaide
Country
Australia
City
Brisbane
Country
Australia
City
Melbourne
Country
Australia
City
Sydney
Country
Australia
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs