PterygiumPhase 3NCT01311960
Topical Bevacizumab for Preventing Recurrent Pterygium
A Phase 3 study testing bevacizumab eye drop 0.05% and normal saline 0.9% in people with Pterygium and Bevacizumab, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium, Bevacizumab, VEGF
- What is being tested?
- bevacizumab eye drop 0.05% and normal saline 0.9%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2010to Apr 2013
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with primary pterygium and plan for pterygium excision with bare sclera by single surgeon. (G.N.)
- Patients with pterygium who understand and can follow the study protocol.
- Patients of age more than 30 years
Who cannot join
- Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial wound healing.
- Patients who are pregnancy or lactation.
- Patients who have a history of allergy to bevacizumab.
- Patients who have a history of allergy to steroid eye drops
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, Chulalongkorn university
Pathumwan, Bangkok, 10330
About this study
Official title: Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial
The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.
Read the detailed description
A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit ocular movement. The mainstay treatment is surgical removal of the head, neck and body of the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably high which is 63% in general. Various adjunctive measures are applied to prevent recurrence including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and amniotic membrane graft. However, each method has its advantages and disadvantages.
The histologic finding of recurrent pterygium often has aggressive fibrovascular growth. Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium tissue, compared with normal conjunctiva and it is also correlated with post-operative recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to its receptors on the surface of vascular endothelial cells. Administration of bevacizumab leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even though there are reported the efficacy of topical bevacizumab in inhibiting the impending recurrent pterygium, there is no study for preventing recurrence after primary pterygium removal.
We conduct a prospective, randomized, double-masked, controlled trial to evaluate the efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary pterygium.
- Conditions
- Pterygium, Bevacizumab, VEGF, Anti-VEGF
- Being tested
- bevacizumab eye drop 0.05%, normal saline 0.9%
- Keywords
- pterygium, recurrent pterygium, bevacizumab, VEGF, anti-VEGF
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab eye drop 0.05%Drug
Also called Study arm
bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
normal saline 0.9%Drug
Also called placebo arm
normal saline eye drop 0.9% will apply 4 times a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab eye drop | Experimental | Not described Receives: Drug: bevacizumab eye drop 0.05% |
| placebo normal saline eye drop | Experimental | Not described Receives: Drug: normal saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recurrence after primary pterygium removal
Measured: 3 months
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Kasetsuwan, Chulalongkorn University
- Investigators
- Ngamjit Kasetsuwan, MD, Principal investigator, Chulalongkorn Universitiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311960
- Sponsor's protocol ID
- IRB No. 227/53
- Status last verified
- Mar 2011
- First submitted
- 1 Dec 2010
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kasetsuwan N, Reinprayoon U, Satitpitakul V. Prevention of recurrent pterygium with topical bevacizumab 0.05% eye drops: a randomized controlled trial. Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.
PubMed 26409291
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial
- ClinicalTrials.gov ID
- NCT01311960
- Acronym / sponsor ID
- IRB No. 227/53
- Conditions
- Pterygium, Bevacizumab, VEGF, Anti-VEGF
- Keywords
- pterygium, recurrent pterygium, bevacizumab, VEGF, anti-VEGF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Mar 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 determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.
Detailed description
A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit ocular movement. The mainstay treatment is surgical removal of the head, neck and body of the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably high which is 63% in general. Various adjunctive measures are applied to prevent recurrence including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and amniotic membrane graft. However, each method has its advantages and disadvantages.
The histologic finding of recurrent pterygium often has aggressive fibrovascular growth. Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium tissue, compared with normal conjunctiva and it is also correlated with post-operative recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to its receptors on the surface of vascular endothelial cells. Administration of bevacizumab leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even though there are reported the efficacy of topical bevacizumab in inhibiting the impending recurrent pterygium, there is no study for preventing recurrence after primary pterygium removal.
We conduct a prospective, randomized, double-masked, controlled trial to evaluate the efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary pterygium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab eye drop | Experimental | Drug: bevacizumab eye drop 0.05% |
| placebo normal saline eye drop | Experimental | Drug: normal saline 0.9% |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are diagnosed with primary pterygium and plan for pterygium excision with bare sclera by single surgeon. (G.N.)
- Patients with pterygium who understand and can follow the study protocol.
- Patients of age more than 30 years
Key exclusion criteria (4 listed)
- Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial wound healing.
- Patients who are pregnancy or lactation.
- Patients who have a history of allergy to bevacizumab.
- Patients who have a history of allergy to steroid eye drops
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 |
|---|---|---|
| bevacizumab eye drop 0.05%Also: Study armbevacizumab eye drop 0.05% will apply 4 times a day for 3 months | Drug | bevacizumab eye drop |
| normal saline 0.9%Also: placebo armnormal saline eye drop 0.9% will apply 4 times a day for 3 months. | Drug | placebo normal saline eye drop |
Primary outcome
rate of recurrence after primary pterygium removal
Time frame: 3 months
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 3 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 9 Apr 2013.
- Derived from this study: PubMed 26409291Kasetsuwan N, Reinprayoon U, Satitpitakul V. Prevention of recurrent pterygium with topical bevacizumab 0.05% eye drops: a randomized controlled trial. Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.
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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.
Ngamjit Kasetsuwan, MD principal investigator
Chulalongkorn Universitiy
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 bevacizumab eye drop 0.05% and normal saline 0.9% in people with Pterygium and Bevacizumab, run by Chulalongkorn 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 3 inclusion and 4 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 9 Apr 2013. 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?
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?
rate of recurrence after primary pterygium removal (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311960, which also lists 1 linked publication.
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 9 Apr 2013.