Bevacizumab for Primary Pterygium Treatment

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686529
• Other study ID #: CC-008-2010
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2012
• Last updated: December 5, 2013
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with primary pterygium

Exclusion Criteria:

• Patients with diabetes mellitus

• collagenopathies,

• previous ocular surgeries,

• pregnant or lactating patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pterygium

Intervention

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.

Locations

Country	Name	City	State
Mexico	Instituto de Oftalmología	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Nava-Castañeda 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 Experiment Oph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pterygium recurrence	The pterygium recurrence is evaluated at one year postoperative	One point.	No
Secondary	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	Yes

External Links

•   This is the link to the reference published on Pubmed