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)

Phase 2CompletedNCT00954057

Neothetics, Inc11 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Thyroid-Related Eye Disease

Interventions

LIPO-102DRUG

intraorbital injection

PlaceboDRUG

intraorbital injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Adelaide, Australia

Unnamed facility

Brisbane, Australia

Unnamed facility

Melbourne, Australia

Unnamed facility

Sydney, Australia

Unnamed facility

Auckland, New Zealand

Outcomes

Primary Outcomes

Safety: physical examinations, laboratory tests, VISA activity score, AE assessments

Time frame: 8 weeks treatment and 1 week follow up

Secondary Outcomes

Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction

Time frame: 8 weeks treatment and 1 week follow up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.