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OpenTrials
Completed

NCT Number: NCT00954057

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.

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Key information

Conditions

Thyroid-Related Eye Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIPO-102

Drug

intraorbital injection

Placebo

Drug

intraorbital injection

Primary outcomes

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

    Time frame: 8 weeks treatment and 1 week follow up

Secondary outcomes

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

    Time frame: 8 weeks treatment and 1 week follow up

Sponsors and collaborators

Lead sponsor

Neothetics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2009
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.