Eye DiseasesPhase 2/3NCT00370734
Effect of Percutaneous Botulinum Toxin A Injection on Natural Course of Upper Lid Retraction in Thyroid Eye Disease
A Phase 2/3 study testing Botulinum toxin A injection in people with Eye Diseases, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Botulinum toxin A injection
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- May 2005to Feb 2007
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy
Who cannot join
- patients in non active phase
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Babak Babsharif, MD
Tehran, Tehran Province, 16666
Babak Babsharif, MD, +98 21 22585952, labbafi@hotmail.com
About this study
In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.
- Conditions
- Eye Diseases
- Being tested
- Botulinum toxin A injection
- Keywords
- botulinum toxin, thyroid eye disease, lid retraction
- Medical subject headings
- Eye Diseases, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A injectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startMay 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Babak Babsharif, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370734
- Sponsor's protocol ID
- 8375
- Status last verified
- Feb 2007
- First submitted
- 31 Aug 2006
- Last updated
- 27 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Percutaneous Botulinum Toxin A Injection on Natural Course of Upper Lid Retraction in Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT00370734
- Acronym / sponsor ID
- 8375
- Conditions
- Eye Diseases
- Keywords
- botulinum toxin, thyroid eye disease, lid retraction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Feb 2007
- First posted
- 1 Sep 2006 (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.
In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy
Key exclusion criteria (1 listed)
- patients in non active phase
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 |
|---|---|---|
| Botulinum toxin A injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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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.
Babak Babsharif, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum toxin A injection in people with Eye Diseases, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Babak Babsharif, MD (+98 21 22585952, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Feb 2007.