Bevacizumab for Primary Pterygium Treatment

Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.

The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Autoconjunctival grafting; Drug: Subconjuntival bevacizumab injection

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06800
    • Instituto de Oftalmología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with primary pterygium

Exclusion Criteria:

• Patients with diabetes mellitus
• collagenopathies,
• previous ocular surgeries,
• pregnant or lactating patients

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One subconjunctival injection; Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery	Procedure: Autoconjunctival grafting; The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.; Drug: Subconjuntival bevacizumab injection; The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.; Other Names: Avastin
Experimental: Two subconjuctival injections; Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery	Procedure: Autoconjunctival grafting; The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.; Drug: Subconjuntival bevacizumab injection; The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.; Other Names: Avastin
Active Comparator: Conventional treatment; Autoconjunctival grafting without subconjuntival bevacizumab injection	Procedure: Autoconjunctival grafting; The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pterygium recurrence	The pterygium recurrence is evaluated at one year postoperative	One point.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conjunctival ischemia	Whiteness of conjunctival bed, that means absence of blood vessels	Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
• Investigators: Principal Investigator: Yonathan Garfias, MD, PhD, Instituto de Oftalmología

Publications and helpful links

General Publications

• Nava-Castaneda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.

Helpful Links

• This is the link to the reference published on Pubmed

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: bevacizumab; Pterygium; autoconjunctival graft
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: CC-008-2010