Back to resultsSafety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
Primary Purpose
Pterygium
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Mitomycin C
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 80
- Presence of primary or recurrent pterygium
- Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
- Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
- The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)
Exclusion Criteria:
- Age less than 18
- Age greater than 80
- Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
- Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
- Any use within the past two months of topical eye drops other than artificial tears in the study eye
- Any previous intravitreal injections of any medication in the study eye
- Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
- Any history of subconjunctival injections in the study eye within the past year
- Any history of scleral or corneal laceration in the study eye
- Ocular surgery within the past 3 months in the study eye
- History of scleral buckle placement in the study eye
- History of glaucoma
Sites / Locations
- Lyndon B. Johnson General Hospital
- Robert Cizik Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab
Mitomycin C
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Who Had Recurrence of Pterygia up to 1 Year
Secondary Outcome Measures
Number of Participants Who Had Complications From the Time of Treatment to Recurrence
Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year
Full Information
NCT ID
NCT01115517
First Posted
April 30, 2010
Last Updated
September 7, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Hermann Eye Center
1. Study Identification
Unique Protocol Identification Number
NCT01115517
Brief Title
Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
Official Title
A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Hermann Eye Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab
Arm Type
Experimental
Arm Title
Mitomycin C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Bevacizumab (Avastin)
Intervention Description
1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Intervention Description
Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Primary Outcome Measure Information:
Title
Number of Participants Who Had Recurrence of Pterygia up to 1 Year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants Who Had Complications From the Time of Treatment to Recurrence
Time Frame
1 year
Title
Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 80
Presence of primary or recurrent pterygium
Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)
Exclusion Criteria:
Age less than 18
Age greater than 80
Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
Any use within the past two months of topical eye drops other than artificial tears in the study eye
Any previous intravitreal injections of any medication in the study eye
Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
Any history of subconjunctival injections in the study eye within the past year
Any history of scleral or corneal laceration in the study eye
Ocular surgery within the past 3 months in the study eye
History of scleral buckle placement in the study eye
History of glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Wang, MD, PhD
Organizational Affiliation
University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Robert Cizik Eye Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
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