Evaluation of Tranilast to Treat Pterygium Before Excision (TPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003613
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : April 18, 2012
Hospital de Base
Information provided by (Responsible Party):
Gildasio Castello de Almeida Junior, Sao Jose do Rio Preto Medical School

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 Type : Interventional  (Clinical Trial)
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 : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : March 2012

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 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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Patient discomfort at day one, six and twelve months Safety of Tranilast [ Time Frame: one day, 6 and 12 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003613

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
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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gildasio Castello de Almeida Junior, Prof. Dr., FAMERP, Sao Jose do Rio Preto Medical School Identifier: NCT01003613     History of Changes
Other Study ID Numbers: 3049/2009
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: April 18, 2012
Last Verified: March 2012

Keywords provided by Gildasio Castello de Almeida Junior, Sao Jose do Rio Preto Medical School:
fibrin glue
primary pterygium
conjunctival autograft

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