NCT03037736

Outpatient Performed Pterygium Surgery Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients will be randomized at enrollment to one of three arms: 5-Fluorouracil (5-FU) 5mg/0.1mL, bevacizumab 2.5mg/0.1mL, or placebo. The placebo will be sterile, preservative-free injectable 0.9% normal saline. All patients will undergo pterygium excision surgery in the minor procedure room using a standardized surgical technique with conjunctival autograft. All patients will have a standardized postoperative drop protocol of neomycin/polymyxin/dexamethasone ointment four times daily for 2 weeks and fluorometholone drops 4 times daily for 2 weeks, three times daily for 2 weeks, twice daily for 2 weeks, once daily for 2 weeks then stopping. At the 1-month and 2-month postoperative visits, patients will receive a subconjunctival injection based on their randomization assignment (5-FU, bevacizumab or placebo) in the area of the excised pterygium at least 1 mm posterior to the limbus. The total injected volume will be 0.1mL for all adjuvants. The primary outcome will pterygium recurrence at 3 months, defined as evidence of at least 1 mm of fibrovascular growth onto the cornea. After the 3 month visit, patients who are determined to have a recurrence will be unmasked, and can received monthly 5-FU or bevacizumab injections at the discretion of the treating physician. Each of these visits will be treated as a study visit, and will be documented. All patients will have study visits at the 6 and 12 month mark. If at any point any patient develops evidence of progression of recurrence, they may undergo further monthly 5-FU or bevacizumab injections at the discretion of the treating physician.

Conditions

• Pterygium of Conjunctiva and Cornea

Interventions

Type	Name	Description
DRUG	5-Fluorouracil	5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.
DRUG	Bevacizumab	Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.
DRUG	Normal saline	Normal saline will be used as the placebo.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2017-01-31
• Last updated: 2021-08-12

Regulatory

• FDA-regulated drug study