Evaluation of Tranilast to Treat Pterygium Before Excision

Pterygium Clinical Trial

— TPS  

Official title:

Evaluation of Tranilast as Adjunctive Therapy Before Primary Pterygium Excision Compared With Conjunctival Autograft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003613
• Other study ID #: 3049/2009
• 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

• Pterygium

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