Recurrent PterygiumPhase 4REPEATNCT02530801
Strategies for Management of Recurrent Pterygium
A Phase 4 study testing Bevacizumab and 5 fluorouracil in people with Recurrent Pterygium, run by University of Nottingham.
Trial summary
Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by causing astigmatism and may encroach on cornea (transparent part of the eye) affecting vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pterygium
- What is being tested?
- Bevacizumab and 5 fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Aug 2018
- 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 over the age of 18
- Patients able to give informed consent- Patients with early recurrent pterygium within 6 months of original excision (conjunctival recurrence or recurrence extending just across the limbus).
- Use of effective contraception in females of childbearing age.
Who cannot join
- Patients under 18 years of age
- Patients unable or refusing to provide informed consent
- Patients who are needle phobic
- Pregnant women, women aiming for conception and breastfeeding women
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with active or suspected ocular or periocular infections.
Show all 9Show fewer
- Patients with active severe intraocular inflammation.
- Patients with raised intraocular pressure or on glaucoma medication
- Patients with advanced recurrent pterygium that extends between the pupil and limbus at the time of presentation
About this study
Official title: Management of Recurrent Pterygium to Prevent Visual Impairment
Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by causing astigmatism and may encroach on cornea (transparent part of the eye) affecting vision. It could cause ocular irritation and can be cosmetically unacceptable especially when inflamed.
Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of your eye), before advancing on to the cornea. Treating the recurrent pterygium before the cornea gets involved avoids repeat surgery, which is difficult and is associated with more scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be stopped before it progresses to true recurrence.
Read more
Several studies attributed the recurrence pf pterygium to the increase of substances as vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF) and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF and fibroblast growth factor.
Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring pterygium has been both safe and effective in treatment of recurrent pterygium.
In many cases, vascularization and inflammation were controlled by subconjunctival Avastin, providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in ophthalmology because of its anti-scarring properties.
The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a challenging condition that usually resists conventional surgery and its rate of recurrence after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by scarring, more risk of intra and post- complications This study aims to generate data to inform further studies towards establishing Avastin and 5 fluouracil as treatment modality for recurrent pterygium.
Read the detailed description
Purpose To assess the efficacy of combined 5FU and Avastin injections in the treatment of recurrent pterygium.
Design Pilot study. The patients will receive combined 5FU and Avastin injection.
Methodology Patients for inclusion in the study will be identified in the specialist corneal clinics at Queens Medical Centre.
5 FU injection
Dose: 0.15 ml of 5FU (3.75mg) will be administered into the body of the recurring pterygium up to 5 injections as determined by response. The 5FU solution is prepared locally in the pharmacy for ophthalmic use. It will be delivered preloaded in a 1ml syringe containing 0.3 ml of 2.5mg 5FU per 0.1ml. The injection will be given under topical anaesthesia. One to two drops of 5% povidone iodine will be instilled in the conjunctival sac 5min before the injection. All injections will be given in the outpatient clinic using a slit lamp. The needle (27Gauge) will be advanced in a zigzag manner into the subconjunctival space, avoiding any large blood vessels, until the middle of the lesion is reached. The solution will be then injected and the needle withdrawn. After the injection, 1-2 drops of chloramphenicol 0.5% preservative free minims will be instilled topically and continued four times a day for 3 days after each injection. Injections will be carried out every two weeks as described above. Patients will have the ability to access the 24 hour on call emergency eye service, and at the same time be provided with contact numbers for investigators for any queries during the study period.
Avastin injection
Dose: 0.15 ml of Avastin (2.5 mg/0.1 ml) will be administered in the body of the recurrent lesion. Up to 5 injections could be given.
The injection will be given under topical anaesthesia. One to two drops of 5% povidone iodine will be instilled in the conjunctival sac 5min before the injection. All injections will be given in the outpatient clinic using a slit lamp. The needle (27Gauge) will be advanced in a zigzag manner into the subconjunctival space, avoiding any large blood vessels, until the middle of the lesion is reached. The solution will be then injected and the needle withdrawn. After the injection, 1-2 drops of chloramphenicol 0.5% preservativefree minims will be instilled topically and continued four times a day for 3 days after each injection. Injections will be carried out every two weeks as described above. Patients will have the ability to access the 24 hour on call emergency eye service, and at the same time be provided with contact numbers for investigators for any queries during the study period.
Fluorescein angiography (FFA) will be done to characterise the conjunctival vessels. It is a safe routine investigation that is done on daily basis in eye clinics.
Patient Inclusion Criteria will be:
- Patients over the age of 18
- Able to give informed consent
- Patients with recurrent pterygium within 6 months of original excision[Recurrence is defined in the protocol (page 22)]
- Use of effective contraception in females of childbearing age
Patient exclusion criteria will be:
- Patients under 18 years of age
- Patients unable or refusing to provide informed consent
- Patients who are needle phobic
- Pregnant women, women aiming for conception and breast feeding women.
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with active or suspected ocular or periocular infections.
- Patients with active severe intraocular inflammation.
- Patients with raised intraocular pressure or on glaucoma medication
- Patients with advanced recurrent pterygium that extends between the pupil and limbus at the time of presentation
In case of bilateral eye involvement, only one eye will be treated with the study drug. The study participants will reserve the right to withdraw from the study at any stage, and will be kept up to date with any new information available about the study medication.
- Conditions
- Recurrent Pterygium
- Being tested
- Bevacizumab, 5 fluorouracil
- 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 Avastin
Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium
5 fluorouracilDrug
Also called ATC code: L01BC02
Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium
| Study group | Role | What they receive |
|---|---|---|
| Avastin and 5 fluorouracil | Other | Subconjunctival injection of bevacizumab combined with 5 fluorouracil Receives: Drug: Bevacizumab; Drug: 5 fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrest of progression of the fibrovascular tissue will be measured using slit lamp (width of the lesion in millimeters)
The width of the lesion will be measured on slit lamp in millimeters
Measured: At 3 month, which is 2 weeks after the last injection
Secondary outcomes (2)
Disappearance of redness of the lesion will be assessed using the slit lamp
Images will be taken using anterior segment slit lamp camera and will be compared for redness by 2 different observers
Measured: At 3 month, which is 2 weeks after the last injection
Return of conjunctiva to normal thickness will be measured using slit lamp (millimeters)
The thicknessof the lesion will be measured on slit lamp in millimeters
Measured: At 3 month, which is 2 weeks after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJan 2017
- Primary completionApr 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent PterygiumStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harminder Dua, Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530801
- Sponsor's protocol ID
- 15073
- Acronym
- REPEAT
- Status last verified
- Nov 2017
- First submitted
- 18 Aug 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Said DG, Faraj LA, Elalfy MS, Yeung A, Miri A, Fares U, Otri AM, Rahman I, Maharajan S, Dua HS. Intra-lesional 5 fluorouracil for the management of recurrent pterygium. Eye (Lond). 2013 Oct;27(10):1123-9. doi: 10.1038/eye.2013.135. Epub 2013 Jun 28.
PubMed 23807385
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Recurrent Pterygium to Prevent Visual Impairment
- ClinicalTrials.gov ID
- NCT02530801
- Acronym / sponsor ID
- REPEAT / 15073
- Conditions
- Recurrent Pterygium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 Aug 2015 (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.
Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by causing astigmatism and may encroach on cornea (transparent part of the eye) affecting vision. It could cause ocular irritation and can be cosmetically unacceptable especially when inflamed.
Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of your eye), before advancing on to the cornea. Treating the recurrent pterygium before the cornea gets involved avoids repeat surgery, which is difficult and is associated with more scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be stopped before it progresses to true recurrence.
Several studies attributed the recurrence pf pterygium to the increase of substances as vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF) and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF and fibroblast growth factor.
Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring pterygium has been both safe and effective in treatment of recurrent pterygium.
In many cases, vascularization and inflammation were controlled by subconjunctival Avastin, providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in ophthalmology because of its anti-scarring properties.
The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a challenging condition that usually resists conventional surgery and its rate of recurrence after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by scarring, more risk of intra and post- complications This study aims to generate data to inform further studies towards establishing Avastin and 5 fluouracil as treatment modality for recurrent pterygium.
Detailed description
Purpose To assess the efficacy of combined 5FU and Avastin injections in the treatment of recurrent pterygium.
Design Pilot study. The patients will receive combined 5FU and Avastin injection.
Methodology Patients for inclusion in the study will be identified in the specialist corneal clinics at Queens Medical Centre.
5 FU injection
Dose: 0.15 ml of 5FU (3.75mg) will be administered into the body of the recurring pterygium up to 5 injections as determined by response. The 5FU solution is prepared locally in the pharmacy for ophthalmic use. It will be delivered preloaded in a 1ml syringe containing 0.3 ml of 2.5mg 5FU per 0.1ml. The injection will be given under topical anaesthesia. One to two drops of 5% povidone iodine will be instilled in the conjunctival sac 5min before the injection. All injections will be given in the outpatient clinic using a slit lamp. The needle (27Gauge) will be advanced in a zigzag manner into the subconjunctival space, avoiding any large blood vessels, until the middle of the lesion is reached. The solution will be then injected and the needle withdrawn. After the injection, 1-2 drops of chloramphenicol 0.5% preservative free minims will be instilled topically and continued four times a day for 3 days after each injection. Injections will be carried out every two weeks as described above. Patients will have the ability to access the 24 hour on call emergency eye service, and at the same time be provided with contact numbers for investigators for any queries during the study period.
Avastin injection
Dose: 0.15 ml of Avastin (2.5 mg/0.1 ml) will be administered in the body of the recurrent lesion. Up to 5 injections could be given.
The injection will be given under topical anaesthesia. One to two drops of 5% povidone iodine will be instilled in the conjunctival sac 5min before the injection. All injections will be given in the outpatient clinic using a slit lamp. The needle (27Gauge) will be advanced in a zigzag manner into the subconjunctival space, avoiding any large blood vessels, until the middle of the lesion is reached. The solution will be then injected and the needle withdrawn. After the injection, 1-2 drops of chloramphenicol 0.5% preservativefree minims will be instilled topically and continued four times a day for 3 days after each injection. Injections will be carried out every two weeks as described above. Patients will have the ability to access the 24 hour on call emergency eye service, and at the same time be provided with contact numbers for investigators for any queries during the study period.
Fluorescein angiography (FFA) will be done to characterise the conjunctival vessels. It is a safe routine investigation that is done on daily basis in eye clinics.
Patient Inclusion Criteria will be:
- Patients over the age of 18
- Able to give informed consent
- Patients with recurrent pterygium within 6 months of original excision[Recurrence is defined in the protocol (page 22)]
- Use of effective contraception in females of childbearing age
Patient exclusion criteria will be:
- Patients under 18 years of age
- Patients unable or refusing to provide informed consent
- Patients who are needle phobic
- Pregnant women, women aiming for conception and breast feeding women.
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with active or suspected ocular or periocular infections.
- Patients with active severe intraocular inflammation.
- Patients with raised intraocular pressure or on glaucoma medication
- Patients with advanced recurrent pterygium that extends between the pupil and limbus at the time of presentation
In case of bilateral eye involvement, only one eye will be treated with the study drug. The study participants will reserve the right to withdraw from the study at any stage, and will be kept up to date with any new information available about the study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin and 5 fluorouracil | Other | Drug: Bevacizumab, Drug: 5 fluorouracilSubconjunctival injection of bevacizumab combined with 5 fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18
- Patients able to give informed consent- Patients with early recurrent pterygium within 6 months of original excision (conjunctival recurrence or recurrence extending just across the limbus).
- Use of effective contraception in females of childbearing age.
Key exclusion criteria (9 listed)
- Patients under 18 years of age
- Patients unable or refusing to provide informed consent
- Patients who are needle phobic
- Pregnant women, women aiming for conception and breastfeeding women
- Patients with hypersensitivity to the active substance or to any of the excipients
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: AvastinSubconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium | Drug | Avastin and 5 fluorouracil |
| 5 fluorouracilAlso: ATC code: L01BC02Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium | Drug | Avastin and 5 fluorouracil |
Primary outcome
Arrest of progression of the fibrovascular tissue will be measured using slit lamp (width of the lesion in millimeters)
Time frame: At 3 month, which is 2 weeks after the last injection
The width of the lesion will be measured on slit lamp in millimeters
2 secondary outcomes
Disappearance of redness of the lesion will be assessed using the slit lamp
Time frame: At 3 month, which is 2 weeks after the last injection
Return of conjunctiva to normal thickness will be measured using slit lamp (millimeters)
Time frame: At 3 month, which is 2 weeks after the last injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Background: PubMed 23807385Said DG, Faraj LA, Elalfy MS, Yeung A, Miri A, Fares U, Otri AM, Rahman I, Maharajan S, Dua HS. Intra-lesional 5 fluorouracil for the management of recurrent pterygium. Eye (Lond). 2013 Oct;27(10):1123-9. doi: 10.1038/eye.2013.135. Epub 2013 Jun 28.
Related trials for Recurrent Pterygium
Not yet recruiting
Comparing Two Surgical Methods to Prevent Pterygium Regrowth
Pterygium
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.
Harminder Dua, Professor principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab and 5 fluorouracil in people with Recurrent Pterygium, run by University of Nottingham.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. 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. 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?
Results are not available in the source record.
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?
Arrest of progression of the fibrovascular tissue will be measured using slit lamp (width of the lesion in millimeters) (time frame: At 3 month, which is 2 weeks after the last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530801, which also lists 1 linked publication.
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 14 Nov 2017.