Bevacizumab for Primary Pterygium Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier:
NCT01686529
First received: September 11, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Pterygium
Procedure: Autoconjunctival grafting
Drug: Subconjuntival bevacizumab injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.

Resource links provided by NLM:


Further study details as provided by Instituto de Oftalmología Fundación Conde de Valenciana:

Primary Outcome Measures:
  • Pterygium recurrence [ Time Frame: One point. ] [ Designated as safety issue: No ]
    The pterygium recurrence is evaluated at one year postoperative


Secondary Outcome Measures:
  • Conjunctival ischemia [ Time Frame: Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative ] [ Designated as safety issue: Yes ]
    Whiteness of conjunctival bed, that means absence of blood vessels


Enrollment: 49
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary pterygium

Exclusion Criteria:

  • Patients with diabetes mellitus
  • collagenopathies,
  • previous ocular surgeries,
  • pregnant or lactating patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686529

Locations
Mexico
Instituto de Oftalmología
Mexico City, Mexico, 06800
Sponsors and Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
Investigators
Principal Investigator: Yonathan Garfias, MD, PhD Instituto de Oftalmología
  More Information

Additional Information:
Publications:
Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT01686529     History of Changes
Other Study ID Numbers: CC-008-2010
Study First Received: September 11, 2012
Last Updated: December 5, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Pterygium
bevacizumab
autoconjunctival graft

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014