Pterygium of the Conjunctiva and CorneaNCT01288404
Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
A study testing Fluorometholone and Bevacizumab in people with Pterygium of the Conjunctiva and Cornea, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pterygium of the Conjunctiva and Cornea
- What is being tested?
- Fluorometholone and Bevacizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2008to Nov 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
- Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
- No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
- No other ocular surface pathologies or coexisting ocular diseases.
- No other ocular surgeries within the previous 6 months.
- No history of allergy to the medications used in this study.
- Good compliance with the study regimen and availability for the duration of the entire study period.
Who cannot join
- Platelet disorders
- Hypertension
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.
Read the detailed description
- Impending recurrent pterygium
- Anti-VEGF therapy
- Bevacizumab
- Subconjunctival injection
- Suppress neovascularization
- Conditions
- Pterygium of the Conjunctiva and Cornea
- Being tested
- Fluorometholone, Bevacizumab
- Keywords
- Bevacizumab, impending recurrent pterygium
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorometholoneDrug
Also called FML eye drops
topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks
BevacizumabDrug
Also called Avastin
subconjunctival bevacizumab 1.25 mg/0.05mL
BevacizumabDrug
Also called Avastin
subconjunctival bevacizumab 2.5 mg/0.1mL
BevacizumabDrug
Also called Avastin
subconjunctival bevacizumab 3.75 mg/0.15mL
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | topical 0.1% fluorometholone eye drops Receives: Drug: Fluorometholone |
| Bevacizumab group 1 | Active comparator | Bevacizumab 1.25 mg/0.05mL Receives: Drug: Bevacizumab |
| Bevacizumab group 2 | Active comparator | Bevacizumab 2.5 mg/0.1mL Receives: Drug: Bevacizumab |
| bevacizumab group 3 | Active comparator | bevacizumab 3.75 mg/0.15mL Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of impending recurrent pterygium
Measured: 3 months
Secondary outcomes (2)
Visual analog scales
Measured: 3 months
Adverse reactions
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 posted2 Feb 2011 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pterygium of the Conjunctiva and CorneaStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kaevalin Lekhanont, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288404
- Sponsor's protocol ID
- 055217
- Status last verified
- Jan 2011
- First submitted
- 1 Feb 2011
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
- ClinicalTrials.gov ID
- NCT01288404
- Acronym / sponsor ID
- 055217
- Conditions
- Pterygium of the Conjunctiva and Cornea
- Keywords
- Bevacizumab, impending recurrent pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Feb 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.
Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.
Detailed description
- Impending recurrent pterygium
- Anti-VEGF therapy
- Bevacizumab
- Subconjunctival injection
- Suppress neovascularization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Fluorometholonetopical 0.1% fluorometholone eye drops |
| Bevacizumab group 1 | Active comparator | Drug: BevacizumabBevacizumab 1.25 mg/0.05mL |
| Bevacizumab group 2 | Active comparator | Drug: BevacizumabBevacizumab 2.5 mg/0.1mL |
| bevacizumab group 3 | Active comparator | Drug: Bevacizumabbevacizumab 3.75 mg/0.15mL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
- Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
- No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
- No other ocular surface pathologies or coexisting ocular diseases.
- No other ocular surgeries within the previous 6 months.
Key exclusion criteria (3 listed)
- Platelet disorders
- Hypertension
- Pregnant or lactating women
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 |
|---|---|---|
| FluorometholoneAlso: FML eye dropstopical 0.1% fluorometholone eye drops 4 times daily for 4 weeks | Drug | Control |
| BevacizumabAlso: Avastinsubconjunctival bevacizumab 1.25 mg/0.05mL | Drug | Bevacizumab group 1 |
| BevacizumabAlso: Avastinsubconjunctival bevacizumab 2.5 mg/0.1mL | Drug | Bevacizumab group 2 |
| BevacizumabAlso: Avastinsubconjunctival bevacizumab 3.75 mg/0.15mL | Drug | bevacizumab group 3 |
Primary outcome
Severity of impending recurrent pterygium
Time frame: 3 months
2 secondary outcomes
Visual analog scales
Time frame: 3 months
Adverse reactions
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 2 Feb 2011.
Related trials for Pterygium of the Conjunctiva and Cornea
Recruiting
Conjunctival Transpositional Surgery for Primary Pterygium
Pterygium of the Conjunctiva and Cornea
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.
Kaevalin Lekhanont, MD principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorometholone and Bevacizumab in people with Pterygium of the Conjunctiva and Cornea, run by Ramathibodi Hospital 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 7 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 2 Feb 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. Some participants in this study may receive a placebo. 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?
Severity of impending recurrent pterygium (time frame: 3 months). 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 2 Feb 2011.