PterygiumPhase 3TPSNCT01003613
Evaluation of Tranilast to Treat Pterygium Before Excision
A Phase 3 study testing Tranilast, and Tissucol and Beriplast P in people with Pterygium, run by Gildasio Castello de Almeida Junior at 1 site in Brazil.
Trial summary
Recurrent or secondary pterygium often has often a growing fibrovascular tissue more exuberant than the primary. Histological findings differ from the primary, since the typical changes in the degenerate connective tissue are absent. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pterygium
- What is being tested?
- Tranilast, and Tissucol and Beriplast P
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary pterygium
Who cannot join
- Keratoconjunctivitis sicca
- Sjögren disease
- Vernal keratoconjunctivitis
- Acne rosacea
- Neurotrophic keratopathy
- Severe dysfunction of the meibomius glands
Show all 9Show fewer
- Use of any immunosuppressive drug, through systemic and topical route
- Aged under 18 years of age and vulnerable groups
- Glaucoma and use of ocular hipotensor
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Base/FAMERP
São José do Rio Preto, São Paulo, 15090-000
About this study
Official title: Evaluation of Tranilast as Adjunctive Therapy Before Primary Pterygium Excision Compared With Conjunctival Autograft
Recurrent or secondary pterygium often has often a growing fibrovascular tissue more exuberant than the primary. Histological findings differ from the primary, since the typical changes in the degenerate connective tissue are absent. The strong immunoreactivity and release of basic fibroblast growth (b-FGF) in cultured fibroblasts of recurrent pterygia suggest that fibroblasts may play an important role in pterygium recurrence. Tranilast used is an antiallergic drug that has an inhibitory effect on the release of chemical transmitters, such as histamine and leukotrienes from mast cells as well as a suppressive effect on vascular permeability.This drug also reduces TGF-β1 production and collagen synthesis in various cells. Tranilast might reduce pterygium recurrence by suppressing TGF-β1 synthesis in conjunctival fibroblast after pterygium surgery. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. Tranilast might be an alternative of mitomycin use, and also less toxic. This study aim to compare the effectiveness of preventing recurrence by using tranilast by topical subconjunctival administration previous to conjunctival autograft transplantation surgery in cases of primary pterygium, and will be perform clinical evaluation and TGF-beta-1 immunohistochemical detection by the anti-TGF-beta 1 antibody as well as fibroblast culture.
Read the detailed description
This is a prospective, randomised, control trial of 50 participants. Twenty five patients in each arm. Twenty five patients undergo standard pterygium excision with the fibrin glue (Tissucol) conjunctival autograft . Twenty five patients undergo pterygium surgery with fibrin glue (Tissucol), and subconjunctival injection of 0.1 ml of Tranilast 1.0% in the head of pterygium 30 days before surgery. Participants will be reviewed, selected, and consented on a pre-assessment day. Surgery will be performed 4 at a time on an all day surgery operating list. Randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. The surgeries will perform by a single surgeon (Almeida Jr, GC). Follow-up will occur at week 1,4, 26, 52. Slit lamp examination will indicate pterygium recurrence. Corneal recurrence will consider when it 0.5 mm of invaded conjunctival tissue,in the clear cornea from the anatomical limbus. The conjunctival recurrence will consider of any size conjunctive fibrovascular invasion inside the graft. The localization and of immunohistochemical will be perform for TGF-B.
- Conditions
- Pterygium
- Being tested
- Tranilast, and Tissucol, Beriplast P
- Keywords
- Tranilast, fibrin glue, primary pterygium, conjunctival autograft
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranilast, and TissucolDrug
Also called Rizaben, Tissucol
1.0%, 0.1 ml, subconjunctival route, single dose
Beriplast POther
Also called Tissucol
0.1 ml to attach graft
| Study group | Role | What they receive |
|---|---|---|
| Tranilast | Active comparator | CAT with FG and Tranilast and MMC 0.02% Receives: Drug: Tranilast, and Tissucol |
| Control | Placebo comparator | CAT with FG and MMC 0.02% Receives: Other: Beriplast P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months
Measured: 6 and 12 months
Secondary outcomes (1)
Patient discomfort at day one, six and twelve months Safety of Tranilast
Measured: one day, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gildasio Castello de Almeida Junior
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Base
- Responsible party
- Sponsor-investigator, Gildasio Castello de Almeida Junior, Sao Jose do Rio Preto Medical School
- Investigators
- Gildasio C Almeida Jr, Prof Dr, Principal investigator, Sao Jose do Rio Preto Medical SchoolSidney JF Sousa, Prof Dr, Study chair, USP - Ribeirão PretoReinaldo Azoubel, Prof Dr, Study director, Prof DrVinicius Tadeu NS Nascimento, Student, Study chair, Sao Jose do Rio Preto Medical SchoolAcacio AS Lima Filho, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003613
- Sponsor's protocol ID
- 3049/2009
- Acronym
- TPS
- Status last verified
- Mar 2012
- First submitted
- 28 Oct 2009
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang M, Zhang JJ, Jackson TL, Sun X, Wu W, Marshall J. Safety and efficacy of intracapsular tranilast microspheres in experimental posterior capsule opacification. J Cataract Refract Surg. 2007 Dec;33(12):2122-8. doi: 10.1016/j.jcrs.2007.07.041.
PubMed 18053915Ji CN, Hu YZ, Ding ZP, Li GG. [The investigation of tranilast on the proliferation and migration of human Tenon's capsule fibroblasts]. Zhonghua Yan Ke Za Zhi. 2004 Mar;40(3):165-9. Chinese.
PubMed 15307986Yasukawa T, Kimura H, Dong J, Tabata Y, Miyamoto H, Honda Y, Ogura Y. Effect of tranilast on proliferation, collagen gel contraction, and transforming growth factor beta secretion of retinal pigment epithelial cells and fibroblasts. Ophthalmic Res. 2002 Jul-Aug;34(4):206-12. doi: 10.1159/000063884.
PubMed 12297693Almeida Junior GC, Arakawa L, Santi Neto Dd, Cury PM, Lima Filho AA, Sousa SJ, Alves MR, Azoubel R. Preoperative tranilast as adjunctive therapy to primary pterygium surgery with a 1-year follow-up. Arq Bras Oftalmol. 2015 Jan-Feb;78(1):1-5. doi: 10.5935/0004-2749.20150002.
PubMed 25714528
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tranilast as Adjunctive Therapy Before Primary Pterygium Excision Compared With Conjunctival Autograft
- ClinicalTrials.gov ID
- NCT01003613
- Acronym / sponsor ID
- TPS / 3049/2009
- Conditions
- Pterygium
- Keywords
- Tranilast, fibrin glue, primary pterygium, conjunctival autograft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gildasio Castello de Almeida JuniorUniversity, hospital or other
- Collaborators
- Hospital de Base
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Oct 2009 (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.
Recurrent or secondary pterygium often has often a growing fibrovascular tissue more exuberant than the primary. Histological findings differ from the primary, since the typical changes in the degenerate connective tissue are absent. The strong immunoreactivity and release of basic fibroblast growth (b-FGF) in cultured fibroblasts of recurrent pterygia suggest that fibroblasts may play an important role in pterygium recurrence. Tranilast used is an antiallergic drug that has an inhibitory effect on the release of chemical transmitters, such as histamine and leukotrienes from mast cells as well as a suppressive effect on vascular permeability.This drug also reduces TGF-β1 production and collagen synthesis in various cells. Tranilast might reduce pterygium recurrence by suppressing TGF-β1 synthesis in conjunctival fibroblast after pterygium surgery. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. Tranilast might be an alternative of mitomycin use, and also less toxic. This study aim to compare the effectiveness of preventing recurrence by using tranilast by topical subconjunctival administration previous to conjunctival autograft transplantation surgery in cases of primary pterygium, and will be perform clinical evaluation and TGF-beta-1 immunohistochemical detection by the anti-TGF-beta 1 antibody as well as fibroblast culture.
Detailed description
This is a prospective, randomised, control trial of 50 participants. Twenty five patients in each arm. Twenty five patients undergo standard pterygium excision with the fibrin glue (Tissucol) conjunctival autograft . Twenty five patients undergo pterygium surgery with fibrin glue (Tissucol), and subconjunctival injection of 0.1 ml of Tranilast 1.0% in the head of pterygium 30 days before surgery. Participants will be reviewed, selected, and consented on a pre-assessment day. Surgery will be performed 4 at a time on an all day surgery operating list. Randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. The surgeries will perform by a single surgeon (Almeida Jr, GC). Follow-up will occur at week 1,4, 26, 52. Slit lamp examination will indicate pterygium recurrence. Corneal recurrence will consider when it 0.5 mm of invaded conjunctival tissue,in the clear cornea from the anatomical limbus. The conjunctival recurrence will consider of any size conjunctive fibrovascular invasion inside the graft. The localization and of immunohistochemical will be perform for TGF-B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranilast | Active comparator | Drug: Tranilast, and TissucolCAT with FG and Tranilast and MMC 0.02% |
| Control | Placebo comparator | Other: Beriplast PCAT with FG and MMC 0.02% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary pterygium
Key exclusion criteria (9 listed)
- Keratoconjunctivitis sicca
- Sjögren disease
- Vernal keratoconjunctivitis
- Acne rosacea
- Neurotrophic keratopathy
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 |
|---|---|---|
| Tranilast, and TissucolAlso: Rizaben, Tissucol1.0%, 0.1 ml, subconjunctival route, single dose | Drug | Tranilast |
| Beriplast PAlso: Tissucol0.1 ml to attach graft | Other | Control |
Primary outcome
Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months
Time frame: 6 and 12 months
1 secondary outcome
Patient discomfort at day one, six and twelve months Safety of Tranilast
Time frame: one day, 6 and 12 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 18 Apr 2012.
- Results publication: PubMed 18053915Wang M, Zhang JJ, Jackson TL, Sun X, Wu W, Marshall J. Safety and efficacy of intracapsular tranilast microspheres in experimental posterior capsule opacification. J Cataract Refract Surg. 2007 Dec;33(12):2122-8. doi: 10.1016/j.jcrs.2007.07.041.
- Results publication: PubMed 15307986Ji CN, Hu YZ, Ding ZP, Li GG. [The investigation of tranilast on the proliferation and migration of human Tenon's capsule fibroblasts]. Zhonghua Yan Ke Za Zhi. 2004 Mar;40(3):165-9. Chinese.
- Results publication: PubMed 12297693Yasukawa T, Kimura H, Dong J, Tabata Y, Miyamoto H, Honda Y, Ogura Y. Effect of tranilast on proliferation, collagen gel contraction, and transforming growth factor beta secretion of retinal pigment epithelial cells and fibroblasts. Ophthalmic Res. 2002 Jul-Aug;34(4):206-12. doi: 10.1159/000063884.
- Derived from this study: PubMed 25714528Almeida Junior GC, Arakawa L, Santi Neto Dd, Cury PM, Lima Filho AA, Sousa SJ, Alves MR, Azoubel R. Preoperative tranilast as adjunctive therapy to primary pterygium surgery with a 1-year follow-up. Arq Bras Oftalmol. 2015 Jan-Feb;78(1):1-5. doi: 10.5935/0004-2749.20150002.
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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.
Gildasio C Almeida Jr, Prof Dr principal investigator
Sao Jose do Rio Preto Medical School
Sidney JF Sousa, Prof Dr study chair
USP - Ribeirão Preto
Reinaldo Azoubel, Prof Dr study director
Prof Dr
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 Tranilast, and Tissucol and Beriplast P in people with Pterygium, run by Gildasio Castello de Almeida Junior 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 9 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 18 Apr 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. 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.
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?
Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months (time frame: 6 and 12 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 NCT01003613, which also lists 4 linked publications.
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 18 Apr 2012.