Back to resultsRandomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Primary Purpose
Pterygium of the Conjunctiva and Cornea
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Fluorometholone
Bevacizumab
Bevacizumab
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium of the Conjunctiva and Cornea focused on measuring Bevacizumab, impending recurrent pterygium
Eligibility Criteria
Inclusion Criteria:
- Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
- Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
- No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
- No other ocular surface pathologies or coexisting ocular diseases.
- No other ocular surgeries within the previous 6 months.
- No history of allergy to the medications used in this study.
- Good compliance with the study regimen and availability for the duration of the entire study period.
Exclusion Criteria:
- Platelet disorders
- Hypertension
- Pregnant or lactating women
Sites / Locations
- Ramathibodi Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control
Bevacizumab group 1
Bevacizumab group 2
bevacizumab group 3
Arm Description
topical 0.1% fluorometholone eye drops
Bevacizumab 1.25 mg/0.05mL
Bevacizumab 2.5 mg/0.1mL
bevacizumab 3.75 mg/0.15mL
Outcomes
Primary Outcome Measures
Severity of impending recurrent pterygium
Secondary Outcome Measures
Visual analog scales
Adverse reactions
Full Information
NCT ID
NCT01288404
First Posted
February 1, 2011
Last Updated
February 1, 2011
Sponsor
Ramathibodi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01288404
Brief Title
Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Official Title
A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ramathibodi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.
Detailed Description
Impending recurrent pterygium
Anti-VEGF therapy
Bevacizumab
Subconjunctival injection
Suppress neovascularization
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium of the Conjunctiva and Cornea
Keywords
Bevacizumab, impending recurrent pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
topical 0.1% fluorometholone eye drops
Arm Title
Bevacizumab group 1
Arm Type
Active Comparator
Arm Description
Bevacizumab 1.25 mg/0.05mL
Arm Title
Bevacizumab group 2
Arm Type
Active Comparator
Arm Description
Bevacizumab 2.5 mg/0.1mL
Arm Title
bevacizumab group 3
Arm Type
Active Comparator
Arm Description
bevacizumab 3.75 mg/0.15mL
Intervention Type
Drug
Intervention Name(s)
Fluorometholone
Other Intervention Name(s)
FML eye drops
Intervention Description
topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
subconjunctival bevacizumab 1.25 mg/0.05mL
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
subconjunctival bevacizumab 2.5 mg/0.1mL
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
subconjunctival bevacizumab 3.75 mg/0.15mL
Primary Outcome Measure Information:
Title
Severity of impending recurrent pterygium
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual analog scales
Time Frame
3 months
Title
Adverse reactions
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
No other ocular surface pathologies or coexisting ocular diseases.
No other ocular surgeries within the previous 6 months.
No history of allergy to the medications used in this study.
Good compliance with the study regimen and availability for the duration of the entire study period.
Exclusion Criteria:
Platelet disorders
Hypertension
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaevalin Lekhanont, MD
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
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