CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 32 enrolled
Drug / intervention
Tranilast, and Tissucol +1 moredrug
Likely dose
Tranilast, and Tissucol 0.1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01003613
NCT01003613Phase 3Completed

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

Gildasio Castello de Almeida Junior·interventional·Posted Oct 29, 2009·Updated Apr 18, 2012

In Brief

A Phase 3 clinical trial evaluating Tranilast, and Tissucol and Beriplast P for Pterygium. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPterygium
CountriesBrazil
CollaboratorsHospital de Base

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJul 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.7 years ago

Interventions

Tranilast, and Tissucoldrug

1.0%, 0.1 ml, subconjunctival route, single dose

Beriplast Pother

0.1 ml to attach graft