Recurrent PterygiumPhase 2/3BRPNCT01744756
Subconjunctival Bevacizumab and Recurrent Pterygium
A Phase 2/3 study testing Bevacizumab in people with Recurrent Pterygium, run by Instituto de Olhos de Goiania at 1 site in Brazil.
Trial summary
A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Recurrent Pterygium
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Sep 2012
- Phase
- Phase 2/3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent pterygium
Who cannot join
- Pregnant or lactating women
- History of myocardial infarction
- History of stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.
Read the detailed description
- Pacients with recurrent pterygium
- Anti-VEGF therapy -Bevacizumab
- Conditions
- Recurrent Pterygium
- Being tested
- Bevacizumab
- Keywords
- Subconjunctival Bevacizumab, Recurrent pterygium
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
One subconjunctival aplication of Bevacizumabe 0,5ml
| Study group | Role | What they receive |
|---|---|---|
| Subconjunctival Bevacizumab | Experimental | One aplication of subconjunctival Bevacizumab 0,5 ml Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pterygium size after subconjunctival bevacizumab
-Size of recurrent pterygium (measured in mm) after injection
Measured: 8 weeks
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
-Number of patients with hyposphagma and irritative symptoms after subconjunctival injection
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionSep 2012
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 Recurrent 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa S Stival, MD, Study chair, Instituto de Olhos de Goiania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744756
- Sponsor's protocol ID
- pterygium bevacizumab
- Acronym
- BRP
- Status last verified
- Dec 2012
- First submitted
- 29 Nov 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7. doi: 10.5935/0004-2749.20140003.
PubMed 25076364
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
- ClinicalTrials.gov ID
- NCT01744756
- Acronym / sponsor ID
- BRP / pterygium bevacizumab
- Conditions
- Recurrent Pterygium
- Keywords
- Subconjunctival Bevacizumab, Recurrent pterygium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Dec 2012 (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.
A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.
Detailed description
- Pacients with recurrent pterygium
- Anti-VEGF therapy -Bevacizumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subconjunctival Bevacizumab | Experimental | Drug: BevacizumabOne aplication of subconjunctival Bevacizumab 0,5 ml |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recurrent pterygium
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- History of myocardial infarction
- History of stroke
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: AvastinOne subconjunctival aplication of Bevacizumabe 0,5ml | Drug | Subconjunctival Bevacizumab |
Primary outcome
Pterygium size after subconjunctival bevacizumab
Time frame: 8 weeks
-Size of recurrent pterygium (measured in mm) after injection
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
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 7 Dec 2012.
- Derived from this study: PubMed 25076364Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7. doi: 10.5935/0004-2749.20140003.
Related trials for Recurrent Pterygium
Not yet recruiting
Comparing Two Surgical Methods to Prevent Pterygium Regrowth
Pterygium
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.
Larissa S Stival, MD study chair
Instituto de Olhos de Goiania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bevacizumab in people with Recurrent Pterygium, run by Instituto de Olhos de Goiania at 1 site in Brazil.
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 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 7 Dec 2012. 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pterygium size after subconjunctival bevacizumab (time frame: 8 weeks). 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 NCT01744756, 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 7 Dec 2012.