BlebNCT00644215
Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure
A study testing 5-FU and Mitomycin in people with Bleb, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure . Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Bleb
- What is being tested?
- 5-FU and Mitomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Jun 2007to Feb 2009
- Phase
- Interventional
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy\&phaco which not respond to high frequent topical steroids or removal of releasable sutures
Who cannot join
- Injected bleb due to complications of surgery such as button hole formation
- Injected bleb due to blebitis
- Bleb leakage
- Flat AC
- Pregnant or nursing mothers
- Injected bleb after bleb reconstruction
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,
Tehran, Tehran Province, 16666
Mohammad Pakravan, Associated professor l, 22590607, mopakravan@yahoo.com
Mohammad Pakravan, Assosiated professor
About this study
Official title: Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure .
Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.
- Conditions
- Bleb
- Being tested
- 5-FU and Mitomycin
- Keywords
- injected bleb, mitomycin drop, 5-Fu injection, early bleb failure
- Medical subject headings
- Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FU and MitomycinDrug
- 5-FU injection 5mg
- Mitomycin drop 0.02%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5-FU injection has been done Receives: Drug: 5-FU and Mitomycin |
| 2 | Experimental | Mitomycin drop has been administrated Receives: Drug: 5-FU and Mitomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iop and Bleb height,extent and vascularity
Measured: At least in 3 months of follow up
Secondary outcomes (1)
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlebStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644215
- Sponsor's protocol ID
- 8662
- Status last verified
- Jun 2008
- First submitted
- 24 Mar 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00644215
- Acronym / sponsor ID
- 8662
- Conditions
- Bleb
- Keywords
- injected bleb, mitomycin drop, 5-Fu injection, early bleb failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (estimated)
- First posted
- 26 Mar 2008 (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.
purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure .
Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 5-FU and Mitomycin5-FU injection has been done |
| 2 | Experimental | Drug: 5-FU and MitomycinMitomycin drop has been administrated |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy\&phaco which not respond to high frequent topical steroids or removal of releasable sutures
Key exclusion criteria (6 listed)
- Injected bleb due to complications of surgery such as button hole formation
- Injected bleb due to blebitis
- Bleb leakage
- Flat AC
- Pregnant or nursing mothers
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 |
|---|---|---|
| 5-FU and Mitomycin* 5-FU injection 5mg * Mitomycin drop 0.02% | Drug | 1, 2 |
Primary outcome
Iop and Bleb height,extent and vascularity
Time frame: At least in 3 months of follow up
1 secondary outcome
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-FU and Mitomycin in people with Bleb, 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 6 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 17 Jun 2008. 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.
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 Mohammad pakravan, associated professor (22590607 ext. 009821, mopakravan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iop and Bleb height,extent and vascularity (time frame: At least in 3 months of 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 17 Jun 2008.