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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01003613
Other study ID # 3049/2009
Secondary ID
Status Completed
Phase Phase 3
First received October 28, 2009
Last updated April 16, 2012
Start date February 2009
Est. completion date March 2012

Study information

Verified date March 2012
Source Sao Jose do Rio Preto University
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 2012
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Primary pterygium

Exclusion Criteria:

- Keratoconjunctivitis sicca

- Sjögren disease

- Vernal keratoconjunctivitis

- Acne rosacea

- Neurotrophic keratopathy

- Severe dysfunction of the meibomius glands

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tranilast, and Tissucol
1.0%, 0.1 ml, subconjunctival route, single dose
Other:
Beriplast P
0.1 ml to attach graft

Locations

Country Name City State
Brazil Hospital de Base/FAMERP Sao Jose do Rio Preto Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
Gildasio Castello de Almeida Junior Hospital de Base

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Ji 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. — View Citation

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. — View Citation

Yasukawa 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 J — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months 6 and 12 months Yes
Secondary Patient discomfort at day one, six and twelve months Safety of Tranilast one day, 6 and 12 months Yes
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