Clinical trial NCT01003613: Evaluation of Tranilast to Treat Pterygium Before Excision
Official title: Evaluation of Tranilast as Adjunctive Therapy Before Primary Pterygium Excision Compared With Conjunctival Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pterygium
Keywords: Tranilast
fibrin glue
primary pterygium
conjunctival autograft
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
Collaborators: name: Hospital de Base
First posted: 2009-10-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Recurrence rate at months six and twelve months Immunohistochemical and cell morphology analysis at the end of study, 12 months
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Patient discomfort at day one, six and twelve months Safety of Tranilast
timeFrame: one day, 6 and 12 months
Other outcomes:
Locations:
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base/FAMERP
state: Sao Paulo
Study officials:
affiliation: Sao Jose do Rio Preto Medical School
name: Gildasio C Almeida Jr, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: USP - Ribeirão Preto
name: Sidney JF Sousa, Prof Dr
role: STUDY_CHAIR
affiliation: Prof Dr
name: Reinaldo Azoubel, Prof Dr
role: STUDY_DIRECTOR
affiliation: Sao Jose do Rio Preto Medical School
name: Vinicius Tadeu NS Nascimento, Student
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Acacio AS Lima Filho, MD
role: STUDY_CHAIR
References:
citation: Wang M, Zhang JJ, Jackson TL, Sun X, Wu W, Marshall J. Safety and efficacy of intracapsular tranilast microspheres in experimental posterior capsule opacification. J Cataract Refract Surg. 2007 Dec;33(12):2122-8. doi: 10.1016/j.jcrs.2007.07.041.
citation: Ji CN, Hu YZ, Ding ZP, Li GG. [The investigation of tranilast on the proliferation and migration of human Tenon's capsule fibroblasts]. Zhonghua Yan Ke Za Zhi. 2004 Mar;40(3):165-9. Chinese.
citation: Yasukawa T, Kimura H, Dong J, Tabata Y, Miyamoto H, Honda Y, Ogura Y. Effect of tranilast on proliferation, collagen gel contraction, and transforming growth factor beta secretion of retinal pigment epithelial cells and fibroblasts. Ophthalmic Res. 2002 Jul-Aug;34(4):206-12. doi: 10.1159/000063884.
citation: Almeida Junior GC, Arakawa L, Santi Neto Dd, Cury PM, Lima Filho AA, Sousa SJ, Alves MR, Azoubel R. Preoperative tranilast as adjunctive therapy to primary pterygium surgery with a 1-year follow-up. Arq Bras Oftalmol. 2015 Jan-Feb;78(1):1-5. doi: 10.5935/0004-2749.20150002.