Thyroid-Related Eye Disease Clinical Trial
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
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Neothetics, Inc |
Australia, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: physical examinations, laboratory tests, VISA activity score, AE assessments | 8 weeks treatment and 1 week follow up | No | |
| Secondary | Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction | 8 weeks treatment and 1 week follow up | No |