Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

NCT01736449 | Completed Phase 4

• 1 other identifier: IRB1108
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pterygium

Keywords

pterygium; bevacizumab; recurrence of pterygium

Outcome Measures

Primary Outcomes (1)

• number of recurrent pterygia with postoperative bevacizumab

  The number of recurrent pterygia with patients who received bevacizumab after pterygium excision was compared to the number of recurrences in those patients who only had pterygium excision.

  6 months

Study Arms (2)

Pterygium Excision Alone

PLACEBO COMPARATOR

Pterygium Excision with Bevacizumab Injection

EXPERIMENTAL

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Pterygium Excision with Bevacizumab Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• history of glaucoma
• previous ocular surgery
• steroid-response glaucoma
• previous myocardial infarct
• bleeding disorder
• pregnancy
• lack of patient cooperation

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92624, United States

Location

Related Publications (21)

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  PMID: 19288018 BACKGROUND

• 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.

  PMID: 20198298 BACKGROUND

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

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

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  PMID: 20885313 BACKGROUND

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  PMID: 20977367 BACKGROUND

• 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.

  PMID: 19887878 BACKGROUND

• 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.

  PMID: 22081150 BACKGROUND

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  PMID: 20021250 BACKGROUND

• 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.

  PMID: 21955635 BACKGROUND

• 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.

  PMID: 20625050 BACKGROUND

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  PMID: 17057166 BACKGROUND

• 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.

  PMID: 20463798 BACKGROUND

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

  PMID: 19668504 BACKGROUND

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  PMID: 16508423 BACKGROUND

MeSH Terms

Conditions

Pterygium

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Keith Tokuhara, MD

  Arrowhead Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 29, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

US (1)