Topical Bevacizumab for Preventing Recurrent Pterygium

NCT01311960 | Completed Phase 3 DMC

• 1 other identifier: IRB No. 227/53
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.

Conditions

Pterygium; Bevacizumab; VEGF; Anti-VEGF

Keywords

pterygium; recurrent pterygium; bevacizumab; VEGF; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• rate of recurrence after primary pterygium removal

  3 months

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  3 months

Study Arms (2)

bevacizumab eye drop

EXPERIMENTAL

Drug: bevacizumab eye drop 0.05%

placebo normal saline eye drop

EXPERIMENTAL

Drug: normal saline 0.9%

Interventions

bevacizumab eye drop 0.05% DRUG

bevacizumab eye drop 0.05% will apply 4 times a day for 3 months

Also known as: Study arm

bevacizumab eye drop

normal saline 0.9% DRUG

normal saline eye drop 0.9% will apply 4 times a day for 3 months.

Also known as: placebo arm

placebo normal saline eye drop

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are diagnosed with primary pterygium and plan for pterygium excision with bare sclera by single surgeon. (G.N.)
• Patients with pterygium who understand and can follow the study protocol.
• Patients of age more than 30 years

You may not qualify if:

• Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial wound healing.
• Patients who are pregnancy or lactation.
• Patients who have a history of allergy to bevacizumab.
• Patients who have a history of allergy to steroid eye drops

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of medicine, Chulalongkorn university

Pathumwan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Kasetsuwan N, Reinprayoon U, Satitpitakul V. Prevention of recurrent pterygium with topical bevacizumab 0.05% eye drops: a randomized controlled trial. Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.

  PMID: 26409291 DERIVED

MeSH Terms

Conditions

Pterygium

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ngamjit Kasetsuwan, MD

  Chulalongkorn Universitiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: March 10, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2011-03

Locations

TH (1)