Thyroid-Related Eye DiseasePhase 2NCT00954057
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)
A Phase 2 study testing LIPO-102 in people with Thyroid-Related Eye Disease, run by Neothetics, Inc at 5 sites in 2 countries.
Trial summary
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid-Related Eye Disease
- What is being tested?
- LIPO-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Non pregnant female
- Symptomatic exophthalmos
- Inactive Thyroid Eye Disease
- Signed informed consent
Who cannot join
- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Study site
Adelaide
Study site
Brisbane
Study site
Melbourne
Study site
Sydney
About this study
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.
- Conditions
- Thyroid-Related Eye Disease
- Being tested
- LIPO-102, Placebo
- Keywords
- TED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-102Drug
intraorbital injection
PlaceboDrug
intraorbital injection
| Study group | Role | What they receive |
|---|---|---|
| LIPO-102 | Experimental | Intraorbital Injection Receives: Drug: LIPO-102 |
| Placebo | Placebo comparator | Intraorbital Injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Measured: 8 weeks treatment and 1 week follow up
Secondary outcomes (1)
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
Measured: 8 weeks treatment and 1 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid-Related Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954057
- Sponsor's protocol ID
- LIPO-102-CL-06
- Status last verified
- Mar 2015
- First submitted
- 4 Aug 2009
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00954057
- Acronym / sponsor ID
- LIPO-102-CL-06
- Conditions
- Thyroid-Related Eye Disease
- Keywords
- TED
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIPO-102 | Experimental | Drug: LIPO-102Intraorbital Injection |
| Placebo | Placebo comparator | Drug: PlaceboIntraorbital Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Non pregnant female
- Symptomatic exophthalmos
- Inactive Thyroid Eye Disease
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIPO-102intraorbital injection | Drug | LIPO-102 |
| Placebointraorbital injection | Drug | Placebo |
Primary outcome
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Time frame: 8 weeks treatment and 1 week follow up
1 secondary outcome
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
Time frame: 8 weeks treatment and 1 week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIPO-102 in people with Thyroid-Related Eye Disease, run by Neothetics, Inc at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments (time frame: 8 weeks treatment and 1 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.