Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

NCT ID: NCT01736449

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-04-30

Brief Summary

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A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the surface of the cornea. Frequently, these pterygia will recur even after surgical resection. Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab versus pterygium excision alone.

Detailed Description

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This is a prospective trial. Thirty-one patients with a primary pterygium of at least 2 mm in size and without any previous ocular surgery will be included. Outcome measures will include best corrected visual acuity, intraocular pressure, recurrence, and any sight threatening complications at two weeks, two months, and six months postoperatively.

Conditions

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Pterygium

Keywords

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pterygium bevacizumab recurrence of pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pterygium Excision Alone

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Pterygium Excision with Bevacizumab Injection

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Interventions

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Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* any patient 18 years of age or older with a primary pterygium that extends at least 2 mm past the limbus

Exclusion Criteria

* history of glaucoma
* previous ocular surgery
* steroid-response glaucoma
* previous myocardial infarct
* bleeding disorder
* pregnancy
* lack of patient cooperation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sonia Dhoot

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith Tokuhara, MD

Role: PRINCIPAL_INVESTIGATOR

Arrowhead Regional Medical Center

Locations

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Arrowhead Regional Medical Center

Colton, California, United States

Site Status

Countries

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United States

References

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Detorakis ET, Spandidos DA. Pathogenetic mechanisms and treatment options for ophthalmic pterygium: trends and perspectives (Review). Int J Mol Med. 2009 Apr;23(4):439-47. doi: 10.3892/ijmm_00000149.

Reference Type BACKGROUND
PMID: 19288018 (View on PubMed)

Detorakis ET, Zaravinos A, Spandidos DA. Growth factor expression in ophthalmic pterygia and normal conjunctiva. Int J Mol Med. 2010 Apr;25(4):513-6. doi: 10.3892/ijmm_00000371.

Reference Type BACKGROUND
PMID: 20198298 (View on PubMed)

Avisar R, Arnon A, Avisar E, Weinberger D. Primary pterygium recurrence time. Isr Med Assoc J. 2001 Nov;3(11):836-7.

Reference Type BACKGROUND
PMID: 11729580 (View on PubMed)

Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.

Reference Type BACKGROUND
PMID: 12686302 (View on PubMed)

Ang LP, Chua JL, Tan DT. Current concepts and techniques in pterygium treatment. Curr Opin Ophthalmol. 2007 Jul;18(4):308-13. doi: 10.1097/ICU.0b013e3281a7ecbb.

Reference Type BACKGROUND
PMID: 17568207 (View on PubMed)

Enkvetchakul O, Thanathanee O, Rangsin R, Lekhanont K, Suwan-Apichon O. A randomized controlled trial of intralesional bevacizumab injection on primary pterygium: preliminary results. Cornea. 2011 Nov;30(11):1213-8. doi: 10.1097/ICO.0b013e31821c9b44.

Reference Type BACKGROUND
PMID: 21915047 (View on PubMed)

Fallah Tafti MR, Khosravifard K, Mohammadpour M, Hashemian MN, Kiarudi MY. Efficacy of intralesional bevacizumab injection in decreasing pterygium size. Cornea. 2011 Feb;30(2):127-9. doi: 10.1097/ICO.0b013e3181e16d67.

Reference Type BACKGROUND
PMID: 20885313 (View on PubMed)

Banifatemi M, Razeghinejad MR, Hosseini H, Gholampour A. Bevacizumab and ocular wound healing after primary pterygium excision. J Ocul Pharmacol Ther. 2011 Feb;27(1):17-21. doi: 10.1089/jop.2010.0094. Epub 2010 Oct 26.

Reference Type BACKGROUND
PMID: 20977367 (View on PubMed)

Razeghinejad MR, Hosseini H, Ahmadi F, Rahat F, Eghbal H. Preliminary results of subconjunctival bevacizumab in primary pterygium excision. Ophthalmic Res. 2010;43(3):134-8. doi: 10.1159/000252980. Epub 2009 Oct 29.

Reference Type BACKGROUND
PMID: 19887878 (View on PubMed)

Lekhanont K, Patarakittam T, Thongphiew P, Suwan-apichon O, Hanutsaha P. Randomized controlled trial of subconjunctival bevacizumab injection in impending recurrent pterygium: a pilot study. Cornea. 2012 Feb;31(2):155-61. doi: 10.1097/ICO.0b013e3182151e0e.

Reference Type BACKGROUND
PMID: 22081150 (View on PubMed)

Fallah MR, Khosravi K, Hashemian MN, Beheshtnezhad AH, Rajabi MT, Gohari M. Efficacy of topical bevacizumab for inhibiting growth of impending recurrent pterygium. Curr Eye Res. 2010 Jan;35(1):17-22. doi: 10.3109/02713680903395273.

Reference Type BACKGROUND
PMID: 20021250 (View on PubMed)

Shenasi A, Mousavi F, Shoa-Ahari S, Rahimi-Ardabili B, Fouladi RF. Subconjunctival bevacizumab immediately after excision of primary pterygium: the first clinical trial. Cornea. 2011 Nov;30(11):1219-22. doi: 10.1097/ICO.0b013e31820ca63f.

Reference Type BACKGROUND
PMID: 21955635 (View on PubMed)

Cortez RT, Ramirez G, Collet L, Thakuria P, Giuliari GP. Intravitreous bevacizumab injection: an experimental study in New Zealand white rabbits. Arch Ophthalmol. 2010 Jul;128(7):884-7. doi: 10.1001/archophthalmol.2010.139.

Reference Type BACKGROUND
PMID: 20625050 (View on PubMed)

Michels S. Is intravitreal bevacizumab (Avastin) safe? Br J Ophthalmol. 2006 Nov;90(11):1333-4. doi: 10.1136/bjo.2006.102293.

Reference Type BACKGROUND
PMID: 17057166 (View on PubMed)

Ghazi NG, Kirk TQ, Knape RM, Tiedeman JS, Conway BP. Is monthly retreatment with intravitreal bevacizumab (Avastin) necessary in neovascular age-related macular degeneration? Clin Ophthalmol. 2010 Apr 26;4:307-14. doi: 10.2147/opth.s8598.

Reference Type BACKGROUND
PMID: 20463798 (View on PubMed)

El-Batarny AM. Intravitreal bevacizumab treatment for retinal neovascularization and vitreous hemorrhage in proliferative diabetic retinopathy. Clin Ophthalmol. 2007 Jun;1(2):149-55.

Reference Type BACKGROUND
PMID: 19668504 (View on PubMed)

Wong D, Joussen AM. The safety of using anti-VEGF: Is there strength in numbers? Curtis LH, Hammill BG, Schulman KA, Cousins SW (2010) Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration. Arch Ophthalmol 128(10):1273-1279. Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):161-2. doi: 10.1007/s00417-010-1603-7. Epub 2011 Jan 6. No abstract available.

Reference Type BACKGROUND
PMID: 21210141 (View on PubMed)

Grisanti S, Ziemssen F. Bevacizumab: off-label use in ophthalmology. Indian J Ophthalmol. 2007 Nov-Dec;55(6):417-20. doi: 10.4103/0301-4738.36474.

Reference Type BACKGROUND
PMID: 17951896 (View on PubMed)

Yazdani S, Hendi K, Pakravan M. Intravitreal bevacizumab (Avastin) injection for neovascular glaucoma. J Glaucoma. 2007 Aug;16(5):437-9. doi: 10.1097/IJG.0b013e3180457c47.

Reference Type BACKGROUND
PMID: 17700285 (View on PubMed)

Arevalo JF, Sanchez JG, Lasave AF, Wu L, Maia M, Bonafonte S, Brito M, Alezzandrini AA, Restrepo N, Berrocal MH, Saravia M, Farah ME, Fromow-Guerra J, Morales-Canton V. Intravitreal Bevacizumab (Avastin) for Diabetic Retinopathy: The 2010 GLADAOF Lecture. J Ophthalmol. 2011;2011:584238. doi: 10.1155/2011/584238. Epub 2011 Mar 30.

Reference Type BACKGROUND
PMID: 21584260 (View on PubMed)

Manzano RP, Peyman GA, Khan P, Kivilcim M. Testing intravitreal toxicity of bevacizumab (Avastin). Retina. 2006 Mar;26(3):257-61. doi: 10.1097/00006982-200603000-00001.

Reference Type BACKGROUND
PMID: 16508423 (View on PubMed)

Other Identifiers

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IRB1108

Identifier Type: -

Identifier Source: org_study_id