Pterygium
Conditions
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.
Interventions
DRUGBevacizumab
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.
DRUGMitomycin C
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.
Sponsors
Hermann Eye Center
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Had Recurrence of Pterygia up to 1 Year | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Had Complications From the Time of Treatment to Recurrence | 1 year |
| Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year | 1 year |
Countries
United States
Participant flow
Pre-assignment details
51 participants were consented and screened for this study, however only 39 of the 51 met eligibility criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Bevacizumab: 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. | 18 |
| Mitomycin C Mitomycin C: 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. | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Bevacizumab | Mitomycin C | Total |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 11 | 43.9 years STANDARD_DEVIATION 9.4 | 49.3 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Number of Participants Who Had Recurrence of Pterygia up to 1 Year
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Number of Participants Who Had Recurrence of Pterygia up to 1 Year | 0 participants |
| Mitomycin C | Number of Participants Who Had Recurrence of Pterygia up to 1 Year | 3 participants |
Secondary
Number of Participants Who Had Complications From the Time of Treatment to Recurrence
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Number of Participants Who Had Complications From the Time of Treatment to Recurrence | 0 participants |
| Mitomycin C | Number of Participants Who Had Complications From the Time of Treatment to Recurrence | 0 participants |
Secondary
Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year | 0 participants |
| Mitomycin C | Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year | 0 participants |