Bevacizumab for Primary Pterygium Treatment - Full Text View

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:

Drug Information available for: Bevacizumab

U.S. FDA Resources

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

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

No publications provided

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:	September 17, 2012
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 May 19, 2013