Outpatient Performed Pterygium Surgery Study (OPPS)
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|ClinicalTrials.gov Identifier: NCT03037736|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pterygium of Conjunctiva and Cornea||Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Normal saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||patients, physicians and evaluators will be masked as to the assignment arm.|
|Official Title:||Outpatient Performed Pterygium Surgery Study|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||May 1, 2020|
Placebo Comparator: Placebo
Patients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
Drug: Normal saline
Normal saline will be used as the placebo.
Active Comparator: 5-Fluorouracil
Patients 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.
5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.
Active Comparator: Bevacizumab
Patients 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.
Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.
- Recurrence [ Time Frame: 3 months ]Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
- Recurrence [ Time Frame: 6 months ]Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
- Recurrence [ Time Frame: 12 months ]Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037736
|Contact: Julie Schallhorn, MDemail@example.com|