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Completed

NCT Number: NCT01003613

Evaluation of Tranilast to Treat Pterygium Before Excision

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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Base/FAMERP

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranilast, and Tissucol

Drug

1.0%, 0.1 ml, subconjunctival route, single dose

Other names: Rizaben, Tissucol

Beriplast P

Other

0.1 ml to attach graft

Other names: Tissucol

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: one day, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Gildasio Castello de Almeida Junior

Other

Collaborators

  • Hospital de Base

Registry information

Official study title

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

Acronym: TPS

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 29, 2009
Registry last updated
Apr 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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