Evaluation of Tranilast to Treat Pterygium Before Excision (TPS)

April 16, 2012 updated by: Gildasio Castello de Almeida Junior

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Hospital de Base/FAMERP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tranilast
CAT with FG and Tranilast and MMC 0.02%
Drug: Tranilast, and Tissucol
1.0%, 0.1 ml, subconjunctival route, single dose
Other Names:
  • Rizaben, Tissucol
Placebo Comparator: Control
CAT with FG and MMC 0.02%
Other: Beriplast P
0.1 ml to attach graft
Other Names:
  • Tissucol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient discomfort at day one, six and twelve months Safety of Tranilast
Time Frame: one day, 6 and 12 months
one day, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gildasio Castello de Almeida Junior

Collaborators

Hospital de Base

Investigators

  • Principal Investigator: Gildasio C Almeida Jr, Prof Dr, Sao Jose do Rio Preto Medical School
  • Study Chair: Sidney JF Sousa, Prof Dr, USP - Ribeirão Preto
  • Study Director: Reinaldo Azoubel, Prof Dr, Prof Dr
  • Study Chair: Vinicius Tadeu NS Nascimento, Student, Sao Jose do Rio Preto Medical School
  • Study Chair: Acacio AS Lima Filho, MD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3049/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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