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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
Sponsor:
Information provided by (Responsible Party):
Julie Schallhorn, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Pterygium of Conjunctiva and Cornea Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Normal saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: 5-Fluorouracil
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.
Drug: Bevacizumab
Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic single-headed primary pterygia extending 2mm or more onto the cornea and determined by the physician to be a good candidate for surgical excision.
  • Able to express a basic understanding of the study as determined by the treating physician.
  • Age 18 and older.
  • Commitment to return for follow up visits

Exclusion Criteria:

  • Patients who are pregnant or who are planning on becoming pregnant during the study period
  • Patients who are unable to tolerate subconjunctival injections in the clinic setting
  • Patients with a diagnosis of glaucoma who are on more than 1 topical medication to control their intraocular pressure or who have ocular hypertension with a pressure of greater than or equal to 24mmHg.
  • Patients with a previous history of conjunctival surgery in the eye with the pterygium
  • Patients with a history of autoimmune or inflammatory conjunctival or corneal disorders, including but not limited to Stevens Johnson syndrome, graft versus host disease, mucous membrane pemphigoid, severe atopy, and herpes simplex epitheliitis or keratitis.
  • Patients with an allergy to one or more of the study drugs.
  • Patients who are on systemic immunosuppressive therapy or chemotherapy.
  • Patients with a condition requiring topical steroid drops in the study eye or oral prednisone at a dose of more than 5mg/day.
  • Patients with a history of scleritis or other severe ocular surface disease such as limbal stem cell deficiency.
  • Patients with poor vision (defined as VA 20/200 or worse) in the contralateral eye.
  • Patients with a large pterygium judged clinically to need amniotic membrane rather than a conjunctival autograft.
  • Patients with bi-headed pterygia.
  • Patients unable to undergo conjunctival autograft for any reason.
  • Patients who are unable to give informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Julie Schallhorn, MD 4155141927 julie.schallhorn@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Julie Schallhorn, Assistant Professor of Clinical Ophthalmology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03037736     History of Changes
Other Study ID Numbers: OPPS
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors