Pterygium of Conjunctiva and CorneaPhase 4OPPSNCT03037736
Outpatient Performed Pterygium Surgery Study
A Phase 4 study testing 5-Fluorouracil, Bevacizumab and Normal saline in people with Pterygium of Conjunctiva and Cornea, run by University of California, San Francisco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium of Conjunctiva and Cornea
- What is being tested?
- 5-Fluorouracil, Bevacizumab and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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
- Being tested
- 5-Fluorouracil, Bevacizumab, Normal saline
- Medical subject headings
- Pterygium Of Conjunctiva And Cornea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.
BevacizumabDrug
Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.
Normal salineDrug
Normal saline will be used as the placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Mar 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Funding not received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pterygium of Conjunctiva and CorneaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Schallhorn, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037736
- Sponsor's protocol ID
- OPPS
- Acronym
- OPPS
- Status last verified
- Aug 2021
- First submitted
- 27 Jan 2017
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Performed Pterygium Surgery Study
- ClinicalTrials.gov ID
- NCT03037736
- Acronym / sponsor ID
- OPPS / OPPS
- Conditions
- Pterygium of Conjunctiva and Cornea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Normal salinePatients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative. |
| 5-Fluorouracil | Active comparator | Drug: 5-FluorouracilPatients 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. |
| Bevacizumab | Active comparator | Drug: BevacizumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Fluorouracil5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring. | Drug | 5-Fluorouracil |
| BevacizumabBevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders. | Drug | Bevacizumab |
| Normal salineNormal saline will be used as the placebo. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Recurrence
Time frame: 6 months
Recurrence
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Schallhorn, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5-Fluorouracil, Bevacizumab and Normal saline in people with Pterygium of Conjunctiva and Cornea, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.