GlaucomaPhase 4NCT01229202
Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
A Phase 4 study testing Bevacizumab in people with Glaucoma, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Jan 2016
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any type of glaucoma, except neovascular or inflammatory
- patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery
Who cannot join
- younger than 30 years of age
- previous ocular surgeries excepting cataract surgeries
- patients who have had or present with intraocular inflammation
- neovascular glaucoma
- patients who are aphakic
- diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.
The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.
Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.
- Conditions
- Glaucoma
- Being tested
- Bevacizumab
- Keywords
- trabeculectomy, glaucoma surgery, bevacizumab, Vascular Endothelial Growth Inhibitor, glaucoma
- 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
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| standard of care | Active comparator | standard of care for trabeculectomy surgery Receives: Drug: Bevacizumab |
| bevacizumab arm | Active comparator | Not described Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
post surgery IOP (Intra Ocular Pressure Measurement)
Measured: one year post surgery
Secondary outcomes (7)
bleb appearance
Measured: one year post surgery
number of bleb needlings
Measured: one year post surgery
number of glaucoma medications at 12 months postoperatively
Measured: one year post surgery
eye complications
Measured: one year post surgery
systemic complications
Measured: one year post surgery
need for another glaucoma surgery to control glaucoma
Measured: one year post surgery
postoperative visual acuity at 12 months
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJul 2008 (estimated)
- Primary completionDec 2012 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: No REB file
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.
- More trials run by Nova Scotia Health AuthorityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lesya Shuba, MD PhD, Principal investigator, CDHA Halifax Nova Scotia Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229202
- Sponsor's protocol ID
- CD-2007-331
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2010
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
- ClinicalTrials.gov ID
- NCT01229202
- Acronym / sponsor ID
- CD-2007-331
- Conditions
- Glaucoma
- Keywords
- trabeculectomy, glaucoma surgery, bevacizumab, Vascular Endothelial Growth Inhibitor, glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No REB file
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 2008 (estimated)
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 27 Oct 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.
Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.
The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.
Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | Active comparator | Drug: Bevacizumabstandard of care for trabeculectomy surgery |
| bevacizumab arm | Active comparator | Drug: Bevacizumab |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any type of glaucoma, except neovascular or inflammatory
- patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery
Key exclusion criteria (6 listed)
- younger than 30 years of age
- previous ocular surgeries excepting cataract surgeries
- patients who have had or present with intraocular inflammation
- neovascular glaucoma
- patients who are aphakic
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: Avastinsingle bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery | Drug | bevacizumab arm, standard of care |
Primary outcome
post surgery IOP (Intra Ocular Pressure Measurement)
Time frame: one year post surgery
7 secondary outcomes
bleb appearance
Time frame: one year post surgery
number of bleb needlings
Time frame: one year post surgery
number of glaucoma medications at 12 months postoperatively
Time frame: one year post surgery
eye complications
Time frame: one year post surgery
systemic complications
Time frame: one year post surgery
need for another glaucoma surgery to control glaucoma
Time frame: one year post surgery
postoperative visual acuity at 12 months
Time frame: 12 months post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
Lesya Shuba, MD PhD principal investigator
CDHA Halifax Nova Scotia Canada
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 Glaucoma, run by Nova Scotia Health Authority at 1 site in Canada.
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 2 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
post surgery IOP (Intra Ocular Pressure Measurement) (time frame: one year post surgery). 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 21 Aug 2024.