Outpatient Performed Pterygium Surgery Study
- Sponsor
- University of California, San Francisco
- Study ID
- NCT03037736
- Phase
- PHASE4
- Status
- Withdrawn
Conditions
- Pterygium of Conjunctiva and Cornea
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 5-Fluorouracil — DRUG5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.
- Bevacizumab — DRUGBevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.
- Normal saline — DRUGNormal saline will be used as the placebo.
Study Details
This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil subconjunctival injections vs placebo for the recurrence of pterygia after excision using conjunctival autograft.
Key Dates
- First listed
- Jan 31, 2017
- Start date
- Mar 1, 2020
- Status verified
- Aug 2021
- Primary completion
- Mar 1, 2020
- Completion
- Mar 1, 2020
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboPatients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
- Active Comparator: 5-FluorouracilPatients will receive 0.1mL of 5-Fluorouracil, 5mg/0.1mL, injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
- Active Comparator: BevacizumabPatients will receive 0.1mL of bevacizumab, 2.5mg/0.1mL, injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
Primary Outcome Measure
Recurrence [ Time Frame: 3 months ]