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)

Neothetics

Status and phase: Completed; Phase 2

Conditions: Thyroid-Related Eye Disease

Treatments: Drug: LIPO-102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00954057

LIPO-102-CL-06

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

11 participants in 2 patient groups, including a placebo group

LIPO-102

Experimental group

Description:

Intraorbital Injection

Treatment:

Drug: LIPO-102

Placebo

Placebo Comparator group

Description:

Intraorbital Injection

Treatment:

Drug: Placebo