Bleb VascularityPhase 4NCT00815594
Bleb Vascularity Change After Subconjunctival Injection Bevacizumab
A Phase 4 study testing bevacizumab in people with Bleb Vascularity and Conjunctival Scarring, run by Capital Medical University at 1 site in China.
Trial summary
The occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery. Vascular endothelial growth factor is thought to be a key role in the formation of conjunctival scar, which play a pivotal role in the wound-healing process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bleb Vascularity, Conjunctival Scarring
- What is being tested?
- bevacizumab
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to May 2009
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glaucoma patients after trabeculectomy whose bleb is hyperaemia
Who cannot join
- Affected eye has normal IOP
- Not allergic with Avastin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bleb Vascularity Change After Subconjunctival Injection of Bevacizumab
The occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery. Vascular endothelial growth factor is thought to be a key role in the formation of conjunctival scar, which play a pivotal role in the wound-healing process. So it seems that the recombinant human anti-VEGF antibody could inhibit angiogenesis, and reduce the conjunctival vascular formation in the wound-healing process after glaucoma filtering surgery.
- Conditions
- Bleb Vascularity, Conjunctival Scarring
- Being tested
- bevacizumab
- Keywords
- bleb, vascular change, bevacizumab, trabeculectomy, Bleb vascularity associated with increased scarring activity, Conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery, the recombinant human anti-VEGF antibody could inhibit angiogenesis of conjunctiva.
- Medical subject headings
- Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
0.05ml, 1.25mg
What is being measured
The primary outcome is the main question the study is designed to answer.
bleb vascular change
Measured: one day, one week, one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleb VascularityStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Liu Xuan, M.D., Principal investigator, An ophthalmologist in Tongren hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815594
- Sponsor's protocol ID
- 2008TR-LX-001
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleb Vascularity Change After Subconjunctival Injection of Bevacizumab
- ClinicalTrials.gov ID
- NCT00815594
- Acronym / sponsor ID
- 2008TR-LX-001
- Conditions
- Bleb Vascularity, Conjunctival Scarring
- Keywords
- bleb, vascular change, bevacizumab, trabeculectomy, Bleb vascularity associated with increased scarring activity, Conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery, the recombinant human anti-VEGF antibody could inhibit angiogenesis of conjunctiva.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 30 Dec 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.
The occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery. Vascular endothelial growth factor is thought to be a key role in the formation of conjunctival scar, which play a pivotal role in the wound-healing process. So it seems that the recombinant human anti-VEGF antibody could inhibit angiogenesis, and reduce the conjunctival vascular formation in the wound-healing process after glaucoma filtering surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Glaucoma patients after trabeculectomy whose bleb is hyperaemia
Key exclusion criteria (2 listed)
- Affected eye has normal IOP
- Not allergic with Avastin
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 |
|---|---|---|
| bevacizumab0.05ml, 1.25mg | Drug | – |
Primary outcome
bleb vascular change
Time frame: one day, one week, one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2008.
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.
Liu Xuan, M.D. principal investigator
An ophthalmologist in Tongren hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bevacizumab in people with Bleb Vascularity and Conjunctival Scarring, run by Capital Medical University at 1 site in China.
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 2 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 30 Dec 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
bleb vascular change (time frame: one day, one week, one month). 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 30 Dec 2008.