PterygiumPhase 3bevacizumabNCT01380678
Intralesional Bevacizumab Injection on Primary Pterygium
A Phase 3 study testing Intralesional injection of bevacizumab and Topical antihistamine and vasoconstrictor in people with Pterygium and Inflammation, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pterygium, Inflammation
- What is being tested?
- Intralesional injection of bevacizumab and Topical antihistamine and vasoconstrictor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary pterygium
Who cannot join
- previous ocular surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Srinagarind Hospital
Mueng, Changwat Khon Kaen, 40000
Olan Suwan-apichon, MD
About this study
Official title: A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results
The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.
Read the detailed description
To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment
- Conditions
- Pterygium, Inflammation
- Being tested
- Intralesional injection of bevacizumab, Topical antihistamine and vasoconstrictor
- Keywords
- bevacizumab, pterygium, treatment, elevation
- Medical subject headings
- Pterygium, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional injection of bevacizumabDrug
Also called Avastin
single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day
Topical antihistamine and vasoconstrictorDrug
Also called Hista-oph
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Active comparator | intralesional bevacizumab injection Receives: Drug: Intralesional injection of bevacizumab |
| Topical antihistamine and vasoconstrictor | Active comparator | combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04% Receives: Drug: Topical antihistamine and vasoconstrictor |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of corneal pterygium area
Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis [Sony Mavica digital still camera MVC-FD83, Japan]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table.
Number of patients with adverse events will be recorded.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Olan Suwan-apichon, md, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380678
- Sponsor's protocol ID
- KKU-1007
- Acronym
- bevacizumab
- Status last verified
- Jul 2010
- First submitted
- 14 Jun 2010
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results
- ClinicalTrials.gov ID
- NCT01380678
- Acronym / sponsor ID
- bevacizumab / KKU-1007
- Conditions
- Pterygium, Inflammation
- Keywords
- bevacizumab, pterygium, treatment, elevation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Jun 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.
The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.
Detailed description
To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Active comparator | Drug: Intralesional injection of bevacizumabintralesional bevacizumab injection |
| Topical antihistamine and vasoconstrictor | Active comparator | Drug: Topical antihistamine and vasoconstrictorcombination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary pterygium
Key exclusion criteria (1 listed)
- previous ocular surgery
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 |
|---|---|---|
| Intralesional injection of bevacizumabAlso: Avastinsingle dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day | Drug | bevacizumab |
| Topical antihistamine and vasoconstrictorAlso: Hista-ophcombination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04% | Drug | Topical antihistamine and vasoconstrictor |
Primary outcome
percentage of corneal pterygium area
Time frame: 3 years
Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis [Sony Mavica digital still camera MVC-FD83, Japan]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table. Number of patients with adverse events will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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.
Olan Suwan-apichon, md principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intralesional injection of bevacizumab and Topical antihistamine and vasoconstrictor in people with Pterygium and Inflammation, run by Khon Kaen 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 1 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 11 Jul 2011. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olan Suwan-apichon, MD (+66 43 348383, osuwanapichon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of corneal pterygium area (time frame: 3 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 11 Jul 2011.