Evaluation of Tranilast to Treat Pterygium Before Excision

NCT01003613 | Completed Phase 3 DMC

• 1 other identifier: 3049/2009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pterygium

Keywords

Tranilast; fibrin glue; primary pterygium; conjunctival autograft

Outcome Measures

Primary Outcomes (1)

• Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months

  6 and 12 months

Secondary Outcomes (1)

• Patient discomfort at day one, six and twelve months Safety of Tranilast

  one day, 6 and 12 months

Study Arms (2)

Tranilast

ACTIVE COMPARATOR

CAT with FG and Tranilast and MMC 0.02%

Drug: Tranilast, and Tissucol

Control

PLACEBO COMPARATOR

CAT with FG and MMC 0.02%

Other: Beriplast P

Interventions

Tranilast, and Tissucol DRUG

1.0%, 0.1 ml, subconjunctival route, single dose

Also known as: Rizaben, Tissucol

Tranilast

Beriplast P OTHER

0.1 ml to attach graft

Also known as: Tissucol

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary pterygium

You may not qualify if:

• 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

Sponsors & Collaborators

• Gildasio Castello de Almeida Junior: lead
• Hospital de Base: collaborator

Study Sites (1)

Hospital de Base/FAMERP

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 18053915 RESULT

• 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.

  PMID: 15307986 RESULT

• 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 Jul-Aug;34(4):206-12. doi: 10.1159/000063884.

  PMID: 12297693 RESULT

• Almeida 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.

  PMID: 25714528 DERIVED

MeSH Terms

Conditions

Pterygium

Interventions

tranilast; Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Gildasio C Almeida Jr, Prof Dr

  Sao Jose do Rio Preto Medical School

  PRINCIPAL INVESTIGATOR

• Sidney JF Sousa, Prof Dr

  USP - Ribeirão Preto

  STUDY CHAIR

• Reinaldo Azoubel, Prof Dr

  Prof Dr

  STUDY DIRECTOR

• Vinicius Tadeu NS Nascimento, Student

  Sao Jose do Rio Preto Medical School

  STUDY CHAIR

• Acacio AS Lima Filho, MD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr., FAMERP

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 18, 2012

Record last verified: 2012-03

Locations

BR (1)