Complications of TreatmentNCT01425112
Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy
A study testing Phacoemulsification in people with Complications of Treatment and Progression, run by Sudhalkar Eye Hospital.
Trial summary
Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. Read more about this study
- Who is it for?
- Ages 42 years and older
- Conditions the study is for
- Complications of Treatment, Progression
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jun 2011
- 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 42 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Open Angle Glaucoma
- Progression
- Failure to reach target IOP
- Non compliant
Who cannot join
- Resurgery
- Systemic contraindication to bevacizumab
- All other forms of glaucoma
About this study
Official title: Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma
Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.
- Conditions
- Complications of Treatment, Progression
- Being tested
- Phacoemulsification
- Keywords
- trabeculectomy, bevacizumab, anti-VEGF, Efficacy
- Medical subject headings
- Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Surgery for complications of trabeculectomy
| Study group | Role | What they receive |
|---|---|---|
| Topical/Subconjunctival | Experimental | Depending upon the mode of administration Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure control
Measured: For 2 years
Secondary outcomes (1)
Progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startDec 2007
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of TreatmentStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudhalkar Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditya Sudhalkar, Sudhalkar Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425112
- Sponsor's protocol ID
- 31234EH
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01425112
- Acronym / sponsor ID
- 31234EH
- Conditions
- Complications of Treatment, Progression
- Keywords
- trabeculectomy, bevacizumab, anti-VEGF, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sudhalkar Eye HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Aug 2011 (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.
Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical/Subconjunctival | Experimental | Procedure: PhacoemulsificationDepending upon the mode of administration |
Who may qualify
- Ages
- 42 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Open Angle Glaucoma
- Progression
- Failure to reach target IOP
- Non compliant
Key exclusion criteria (3 listed)
- Resurgery
- Systemic contraindication to bevacizumab
- All other forms of 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 |
|---|---|---|
| PhacoemulsificationSurgery for complications of trabeculectomy | Procedure or surgery | Topical/Subconjunctival |
Primary outcome
Intraocular pressure control
Time frame: For 2 years
1 secondary outcome
Progression
Time frame: 2 years
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 29 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification in people with Complications of Treatment and Progression, run by Sudhalkar Eye Hospital.
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 4 inclusion and 3 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 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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 control (time frame: For 2 years). 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 29 Aug 2011.