Evaluation of Tranilast to Treat Pterygium Before Excision (TPS)

This study has been completed.
Sponsor:
Collaborator:
Hospital de Base
Information provided by (Responsible Party):
Gildasio Castello de Almeida Junior, Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT01003613
First received: October 28, 2009
Last updated: April 16, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Pterygium
Drug: Tranilast, and Tissucol
Other: Beriplast P
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Tranilast as Adjunctive Therapy Before Primary Pterygium Excision Compared With Conjunctival Autograft

Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient discomfort at day one, six and twelve months Safety of Tranilast [ Time Frame: one day, 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Rizaben, Tissucol
Placebo Comparator: Control
CAT with FG and MMC 0.02%
Other: Beriplast P
0.1 ml to attach graft
Other Name: Tissucol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01003613

Locations
Brazil
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 University
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 University
Study Chair: Acacio AS Lima Filho, MD Federal University of São Paulo
  More Information

Publications:
Responsible Party: Gildasio Castello de Almeida Junior, Prof. Dr., FAMERP, Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier: NCT01003613     History of Changes
Other Study ID Numbers: 3049/2009
Study First Received: October 28, 2009
Last Updated: April 16, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Sao Jose do Rio Preto University:
Tranilast
fibrin glue
primary pterygium
conjunctival autograft

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Tranilast
Fibrin Tissue Adhesive
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Anti-Allergic Agents
Central Nervous System Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 16, 2014