PterygiumPhase 2NCT01115517
Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
A Phase 2 study testing Bevacizumab and Mitomycin C in people with Pterygium, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pterygium
- What is being tested?
- Bevacizumab and Mitomycin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- Presence of primary or recurrent pterygium
- Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
- Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
- The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)
Who cannot join
- Age less than 18
- Age greater than 80
- Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
- Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
- Any use within the past two months of topical eye drops other than artificial tears in the study eye
- Any previous intravitreal injections of any medication in the study eye
Show all 12Show fewer
- Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
- Any history of subconjunctival injections in the study eye within the past year
- Any history of scleral or corneal laceration in the study eye
- Ocular surgery within the past 3 months in the study eye
- History of scleral buckle placement in the study eye
- History of glaucoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
Robert Cizik Eye Clinic
Houston, Texas, 77030
About this study
Official title: A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.
- Conditions
- Pterygium
- Being tested
- Bevacizumab, Mitomycin C
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Bevacizumab (Avastin)
1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
Mitomycin CDrug
Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab |
| Mitomycin C | Active comparator | Not described Receives: Drug: Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Recurrence of Pterygia up to 1 Year
Measured: 1 year
Secondary outcomes (2)
Number of Participants Who Had Complications From the Time of Treatment to Recurrence
Measured: 1 year
Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hermann Eye Center
- Responsible party
- Principal investigator, Nan Wang, The University of Texas Health Science Center, Houston
- Investigators
- Nan Wang, MD, PhD, Principal investigator, University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115517
- Sponsor's protocol ID
- Pterygium Avastin study
- Status last verified
- Sep 2016
- First submitted
- 30 Apr 2010
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery
- ClinicalTrials.gov ID
- NCT01115517
- Acronym / sponsor ID
- Pterygium Avastin study
- Conditions
- Pterygium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Hermann Eye Center
- Study start
- Oct 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 2 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab |
| Mitomycin C | Active comparator | Drug: Mitomycin C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80
- Presence of primary or recurrent pterygium
- Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
- Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
- The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)
Key exclusion criteria (12 listed)
- Age less than 18
- Age greater than 80
- Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
- Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
- Any use within the past two months of topical eye drops other than artificial tears in the study eye
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 |
|---|---|---|
| BevacizumabAlso: Bevacizumab (Avastin)1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution. | Drug | Bevacizumab |
| Mitomycin CMitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution. | Drug | Mitomycin C |
Primary outcome
Number of Participants Who Had Recurrence of Pterygia up to 1 Year
Time frame: 1 year
2 secondary outcomes
Number of Participants Who Had Complications From the Time of Treatment to Recurrence
Time frame: 1 year
Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nan Wang, MD, PhD principal investigator
University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Mitomycin C in people with Pterygium, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had Recurrence of Pterygia up to 1 Year (time frame: 1 year). 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 21 Oct 2016.