Evaluation of Tranilast to Treat Pterygium Before Excision

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tranilast

CAT with FG and Tranilast and MMC 0.02%

Group Type ACTIVE_COMPARATOR

Tranilast, and Tissucol

Intervention Type DRUG

1.0%, 0.1 ml, subconjunctival route, single dose

Control

CAT with FG and MMC 0.02%

Group Type PLACEBO_COMPARATOR

Beriplast P

Intervention Type OTHER

0.1 ml to attach graft

Interventions

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Tranilast, and Tissucol

1.0%, 0.1 ml, subconjunctival route, single dose

Intervention Type DRUG

Beriplast P

0.1 ml to attach graft

Intervention Type OTHER

Other Intervention Names

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Rizaben, Tissucol Tissucol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes