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 is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.

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

Conditions

• Thyroid-related eye disease

Study Type

Interventional

Study Design

Treatment, Randomised, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

• Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
  [ Time Frame: 8 weeks treatment and 1 week follow up ]
  [ Designated as safety issue: No ]

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 ]
  [ Designated as safety issue: No ]

Study arms and assigned interventions

1. LIPO-102: Experimental Intraorbital Injection:
   • Drug: LIPO-102 intraorbital injection
2. Placebo: Placebo Comparator Intraorbital Injection:
   • Drug: Placebo intraorbital injection

Study Start

September 2009 – February 2010

Eligibility & Criteria

• Ages eligible for study: 18 years to 65 years
• Genders eligible for study: Both
• 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.

Total Enrolment

16

Contact Details

Trinh Le
858 750 1008