Bevacizumab for Primary Pterygium Treatment
Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.
1 other identifier
interventional
49
1 country
1
Brief Summary
The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedDecember 6, 2013
December 1, 2013
11 months
September 11, 2012
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pterygium recurrence
The pterygium recurrence is evaluated at one year postoperative
One point.
Secondary Outcomes (1)
Conjunctival ischemia
Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative
Study Arms (3)
One subconjunctival injection
EXPERIMENTALAutoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
Two subconjuctival injections
EXPERIMENTALAutoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
Conventional treatment
ACTIVE COMPARATORAutoconjunctival grafting without subconjuntival bevacizumab injection
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with primary pterygium
You may not qualify if:
- Patients with diabetes mellitus
- collagenopathies,
- previous ocular surgeries,
- pregnant or lactating patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Oftalmología
Mexico City, Mexico City, 06800, Mexico
Related Publications (1)
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.
PMID: 23777441RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yonathan Garfias, MD, PhD
Instituto de Oftalmología
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 18, 2012
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2012
Last Updated
December 6, 2013
Record last verified: 2013-12