Evaluation of Tranilast to Treat Pterygium Before Excision

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

Interventions

DRUG

Tranilast, and Tissucol

1.0%, 0.1 ml, subconjunctival route, single dose

OTHER

Beriplast P

0.1 ml to attach graft

Sponsors & Collaborators

• Hospital de Base

  collaborator OTHER

• Gildasio Castello de Almeida Junior

  lead OTHER

Principal Investigators

• Gildasio C Almeida Jr, Prof Dr · Sao Jose do Rio Preto Medical School

• Sidney JF Sousa, Prof Dr · USP - Ribeirão Preto

• Reinaldo Azoubel, Prof Dr · Prof Dr

• Vinicius Tadeu NS Nascimento, Student · Sao Jose do Rio Preto Medical School

• Acacio AS Lima Filho, MD · Federal University of São Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2011-07-31

Completion

2012-03-31

Countries

• Brazil

Study Locations