Outpatient Performed Pterygium Surgery Study

NCT03037736 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: OPPS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pterygium of Conjunctiva and Cornea

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Recurrence

  6 months

• Recurrence

  12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

5-Fluorouracil

ACTIVE COMPARATOR

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

Bevacizumab

ACTIVE COMPARATOR

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

Interventions

5-Fluorouracil DRUG

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

5-Fluorouracil

Bevacizumab DRUG

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

Bevacizumab

Normal saline DRUG

Normal saline will be used as the placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Pterygium Of Conjunctiva And Cornea

Interventions

Fluorouracil; Bevacizumab; Saline Solution

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Julie Schallhorn, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patients, physicians and evaluators will be masked as to the assignment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: March 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 12, 2021

Record last verified: 2021-08