TPS: Evaluation of Tranilast to Treat Pterygium Before Excision

Sponsor

Gildasio Castello de Almeida Junior (Other)

Overall Status

Completed

CT.gov ID

NCT01003613

Collaborator

Hospital de Base (Other)

Enrollment

Location

Arms

36.9

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Drug: Tranilast, and Tissucol Other: Beriplast P	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Patient discomfort at day one, six and twelve months Safety of Tranilast [one day, 6 and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Base/FAMERP	Sao Jose do Rio Preto	Sao Paulo	Brazil	15090-000

Sponsors and Collaborators

Gildasio Castello de Almeida Junior
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