GlaucomaPhase 2/3BevacizumabNCT01263834
Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome
A Phase 2/3 study testing Bevacizumab and Mitomycin C in people with Glaucoma, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Bevacizumab and Mitomycin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2010to Jan 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open angle glaucoma with primary mmc-trabeculectomy indication
Who cannot join
- combined phacoemulsification with trabeculectomy
- no more than 6 month of cataract surgery before trabeculectomy
- revised trabeculectomy
- active uveitic glaucoma
- neovascular glaucoma
- par planar vitrectomy
Show all 12Show fewer
- conjunctival surgery
- allergy to bevacizumab or mitomycin C
- ischemic heart disease
- cerebrovascular disease
- renal failure
- liver failure
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial
The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).
Read the detailed description
Prospective interventional clinical trial
Single center, outcome assessor-masked, active control, randomized controlled trial
- Conditions
- Glaucoma
- Being tested
- Bevacizumab, Mitomycin C
- Keywords
- Trabeculectomy, bevacizumab, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
Mitomycin CDrug
Also called MMC
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin c | Active comparator | Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application Receives: Drug: Mitomycin C |
| Bevacizumab | Experimental | Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: 6 month
Secondary outcomes (2)
Bleb characteristic grading
Measured: 6 month
systemic Blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerawat Kiddee, Prince of Songkla University
- Investigators
- Weerawat Kiddee, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263834
- Sponsor's protocol ID
- EC 53-296-02-1-2
- Acronym
- Bevacizumab
- Status last verified
- Jan 2014
- First submitted
- 17 Dec 2010
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01263834
- Acronym / sponsor ID
- Bevacizumab / EC 53-296-02-1-2
- Conditions
- Glaucoma
- Keywords
- Trabeculectomy, bevacizumab, intraocular pressure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Dec 2010 (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 purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).
Detailed description
Prospective interventional clinical trial
Single center, outcome assessor-masked, active control, randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomycin c | Active comparator | Drug: Mitomycin CMitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application |
| Bevacizumab | Experimental | Drug: BevacizumabBevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary open angle glaucoma with primary mmc-trabeculectomy indication
Key exclusion criteria (12 listed)
- combined phacoemulsification with trabeculectomy
- no more than 6 month of cataract surgery before trabeculectomy
- revised trabeculectomy
- active uveitic glaucoma
- neovascular 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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application | Drug | Bevacizumab |
| Mitomycin CAlso: MMCMitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application | Drug | Mitomycin c |
Primary outcome
Intraocular pressure
Time frame: 6 month
2 secondary outcomes
Bleb characteristic grading
Time frame: 6 month
systemic Blood pressure
Time frame: 6 months
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 31 Jan 2014.
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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.
Weerawat Kiddee, MD principal investigator
Prince of Songkla 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 Bevacizumab and Mitomycin C in people with Glaucoma, run by Prince of Songkla University at 1 site in Thailand.
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 12 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 31 Jan 2014. 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 Thailand. 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?
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?
Intraocular pressure (time frame: 6 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 31 Jan 2014.