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Outpatient Performed Pterygium Surgery Study (OPPS)

Primary Purpose

Pterygium of Conjunctiva and Cornea

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

5-Fluorouracil

Bevacizumab

Normal saline

About this trial

This is an interventional treatment trial for Pterygium of Conjunctiva and Cornea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

5-Fluorouracil

Bevacizumab

Arm Description

Patients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.

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.

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.

Outcomes

Primary Outcome Measures

Recurrence

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

Recurrence

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

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.

Full Information

NCT ID

NCT03037736

First Posted

January 27, 2017

Last Updated

August 5, 2021

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT03037736

Brief Title

Outpatient Performed Pterygium Surgery Study

Acronym

OPPS

Official Title

Outpatient Performed Pterygium Surgery Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Funding not received.

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pterygium of Conjunctiva and Cornea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

patients, physicians and evaluators will be masked as to the assignment arm.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.

Arm Title

5-Fluorouracil

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Bevacizumab

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Intervention Description

5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

Normal saline will be used as the placebo.

Primary Outcome Measure Information:

Title

Recurrence

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Recurrence

Description

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.

Time Frame

6 months

Title

Recurrence

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Schallhorn, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Outpatient Performed Pterygium Surgery Study

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