PterygiumPhase 4NCT05314673
Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients
A Phase 4 study testing Preoperative Intra-lesional Bevacizumab Injection in primary pterygium and pterygium surgery without adjunctive therapy in people with Pterygium, run by University Hospital Fattouma Bourguiba at 1 site in Tunisia.
Trial summary
Purpose: To assess the efficacy and safety of a single preoperative intra-lesional bevacizumab injection in primary pterygium. Methods: The investigators conducted a randomized controlled interventional study from January 2019 to December 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Preoperative Intra-lesional Bevacizumab Injection in primary pterygium and pterygium surgery without adjunctive therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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
- clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.
Who cannot join
- unable to attend the whole follow-up
- Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Intra-lesional Bevacizumab Injection in Primary Pterygium in Tunisian Patients: A Randomized Controlled Prospective Study
Purpose: To assess the efficacy and safety of a single preoperative intra-lesional bevacizumab injection in primary pterygium.
Methods: The investigators conducted a randomized controlled interventional study from January 2019 to December 2020. The study included a total of 60 patients (60 eyes) with primary pterygium. The investigators defined two groups of 30 patients each. Group A received an intralesional injection of bevacizumab (Avastin), one month before surgery (lesion excision and conjunctival autograft). Group B (control) had only the surgical treatment. Patients were followed up seven days (D7), one month (M1), three months (M3), and six months (M6) post-operatively. Pre-, per- and post-operatively, photographs of the lesions were taken, as well as a pathological examination. The main outcome measures were the change in functional discomfort following intralesional bevacizumab injection and pterygium recurrence. Recurrence was defined by fibrovascular tissue growth extending more than 1 mm across the limbus. Therapeutic success was defined as the absence of pterygium recurrence in M6.
Read the detailed description
This prospective randomized controlled study adhered to the tenets of the Declaration of Helsinki. The Ethics Committee of our institution approved its modalities. The investigators had informed consent from all participants. The study included a total of 60 eyes of 60 patients with primary pterygium between January 2019 and December 2020. The investigators divided the patients into two groups of 30 patients each. The investigators performed a simple randomization method using a table of random numbers. Group A received an intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment (lesion excision and conjunctival autograft by a single trained surgeon). Group B (control) had only the surgical treatment.
Each patient underwent a complete ocular examination: BSCVA, refraction, slit-lamp biomicroscopy, fundoscopy, and intraocular pressure measurement.
The investigators classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al : 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse). The investigators measured Its corneal surface with Image J software. The study included patients over 18-years-old having primary pterygium with surgical indications:
- Stages 2, 3 and 4
- Significant astigmatism > 1.50 PD
- Patients with significant functional signs: according to a discomfort score that The investigators proposed.
Non-inclusion criteria were recurrent pterygium, suspected pterygium (sentinel vessels, resistant inflammation), and filtering surgery indication. Excluded were patients lost to follow-up or having a bevacizumab contraindication (hypertension, bleeding tendencies, previous myoredial infarction or stroke, pregnant and lactating women).
Pre-operative data gathered included basic demographic information (age and sex), medical and ophthalmological history, and involved eye(s).
The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing, and 5) ocular redness; 6) visual blur, were evaluated according to their severity from 0 to 10 (visual analog scale (VAS)). The investigators assessed this score in each visit.
The surgical technique featured :
- subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus;
- excision of the pterygium, starting from its head, followed by pterygium body removal;
- exposition of a triangular-shaped bare scleral bed (3-4 mm)
- conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All cases were given dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks.
Patients were examined 30 days before Bevacizumab injection (D-30) and surgery and then at D7, M1, M3, and M6 after surgery. The investigators assessed recurrence at each visit. Both groups (day 0: D0) had a per-operative histopathological examination.
- Conditions
- Pterygium
- Being tested
- Preoperative Intra-lesional Bevacizumab Injection in primary pterygium, pterygium surgery without adjunctive therapy
- Keywords
- pterygium, bevacizumab, recurrence, Vascularity, subconjunctival
- Medical subject headings
- Pterygium, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Intra-lesional Bevacizumab Injection in primary pterygiumDrug
The surgical technique featured:
subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All patients received dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks.
Patients were examined 30 days before bevacizumab injection (D-30), before surgery (day 0: D0) and then at D7, M1, M3, and M6 after surgery.
pterygium surgery without adjunctive therapyProcedure or surgery
The surgical technique featured:
subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture
| Study group | Role | What they receive |
|---|---|---|
| Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft | Active comparator | Patients receiving intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment. Surgical treatment consisted of lesion excision and conjunctival autograft performed by a single trained surgeon. Receives: Drug: Preoperative Intra-lesional Bevacizumab Injection in primary pterygium |
| pterygium excision+ autograft | Active comparator | Patients undergoing only pterygium surgical treatment. Receives: Procedure: pterygium surgery without adjunctive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrence
growth of fibrovascular tissue extending more than 1 mm across the limbus.
Measured: 6 months post-operatively
Rate of functional discomfort following intralesional bevacizumab injection
The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing; 5) ocular redness; and 6) visual blurring, were evaluated according to their severity from 0 to 10 (visual analogue scale (VAS)).
Measured: 6 months post-operatively
Secondary outcomes (3)
Rate of mean changes from baseline in BCSVA
one Snellen line
Measured: 6 months post-operatively
Rate of mean changes from baseline in astigmatism
Astigmatism change > 0.25
Measured: 6 months post-operatively
% of patients with change in morphology of pterygium after injection
We classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al: 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khairallah Moncef, University Hospital Fattouma Bourguiba
- Investigators
- Moncef Khairallah, Principal investigator, Monastir University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314673
- Sponsor's protocol ID
- LR18SP09
- Status last verified
- Apr 2022
- First submitted
- 28 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Intra-lesional Bevacizumab Injection in Primary Pterygium in Tunisian Patients: A Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT05314673
- Acronym / sponsor ID
- LR18SP09
- Conditions
- Pterygium
- Keywords
- pterygium, bevacizumab, recurrence, Vascularity, subconjunctival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Fattouma BourguibaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 6 Apr 2022 (actual)
- 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.
Purpose: To assess the efficacy and safety of a single preoperative intra-lesional bevacizumab injection in primary pterygium.
Methods: The investigators conducted a randomized controlled interventional study from January 2019 to December 2020. The study included a total of 60 patients (60 eyes) with primary pterygium. The investigators defined two groups of 30 patients each. Group A received an intralesional injection of bevacizumab (Avastin), one month before surgery (lesion excision and conjunctival autograft). Group B (control) had only the surgical treatment. Patients were followed up seven days (D7), one month (M1), three months (M3), and six months (M6) post-operatively. Pre-, per- and post-operatively, photographs of the lesions were taken, as well as a pathological examination. The main outcome measures were the change in functional discomfort following intralesional bevacizumab injection and pterygium recurrence. Recurrence was defined by fibrovascular tissue growth extending more than 1 mm across the limbus. Therapeutic success was defined as the absence of pterygium recurrence in M6.
Detailed description
This prospective randomized controlled study adhered to the tenets of the Declaration of Helsinki. The Ethics Committee of our institution approved its modalities. The investigators had informed consent from all participants. The study included a total of 60 eyes of 60 patients with primary pterygium between January 2019 and December 2020. The investigators divided the patients into two groups of 30 patients each. The investigators performed a simple randomization method using a table of random numbers. Group A received an intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment (lesion excision and conjunctival autograft by a single trained surgeon). Group B (control) had only the surgical treatment.
Each patient underwent a complete ocular examination: BSCVA, refraction, slit-lamp biomicroscopy, fundoscopy, and intraocular pressure measurement.
The investigators classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al : 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse). The investigators measured Its corneal surface with Image J software. The study included patients over 18-years-old having primary pterygium with surgical indications:
- Stages 2, 3 and 4
- Significant astigmatism > 1.50 PD
- Patients with significant functional signs: according to a discomfort score that The investigators proposed.
Non-inclusion criteria were recurrent pterygium, suspected pterygium (sentinel vessels, resistant inflammation), and filtering surgery indication. Excluded were patients lost to follow-up or having a bevacizumab contraindication (hypertension, bleeding tendencies, previous myoredial infarction or stroke, pregnant and lactating women).
Pre-operative data gathered included basic demographic information (age and sex), medical and ophthalmological history, and involved eye(s).
The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing, and 5) ocular redness; 6) visual blur, were evaluated according to their severity from 0 to 10 (visual analog scale (VAS)). The investigators assessed this score in each visit.
The surgical technique featured :
- subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus;
- excision of the pterygium, starting from its head, followed by pterygium body removal;
- exposition of a triangular-shaped bare scleral bed (3-4 mm)
- conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All cases were given dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks.
Patients were examined 30 days before Bevacizumab injection (D-30) and surgery and then at D7, M1, M3, and M6 after surgery. The investigators assessed recurrence at each visit. Both groups (day 0: D0) had a per-operative histopathological examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft | Active comparator | Drug: Preoperative Intra-lesional Bevacizumab Injection in primary pterygiumPatients receiving intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment. Surgical treatment consisted of lesion excision and conjunctival autograft performed by a single trained surgeon. |
| pterygium excision+ autograft | Active comparator | Procedure: pterygium surgery without adjunctive therapyPatients undergoing only pterygium surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.
Key exclusion criteria (2 listed)
- unable to attend the whole follow-up
- Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).
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 |
|---|---|---|
| Preoperative Intra-lesional Bevacizumab Injection in primary pterygiumThe surgical technique featured: subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All patients received dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks. Patients were examined 30 days before bevacizumab injection (D-30), before surgery (day 0: D0) and then at D7, M1, M3, and M6 after surgery. | Drug | Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft |
| pterygium surgery without adjunctive therapyThe surgical technique featured: subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture | Procedure or surgery | pterygium excision+ autograft |
Primary outcome
Incidence of recurrence
Time frame: 6 months post-operatively
growth of fibrovascular tissue extending more than 1 mm across the limbus.
Rate of functional discomfort following intralesional bevacizumab injection
Time frame: 6 months post-operatively
The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing; 5) ocular redness; and 6) visual blurring, were evaluated according to their severity from 0 to 10 (visual analogue scale (VAS)).
3 secondary outcomes
Rate of mean changes from baseline in BCSVA
Time frame: 6 months post-operatively
Rate of mean changes from baseline in astigmatism
Time frame: 6 months post-operatively
% of patients with change in morphology of pterygium after injection
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
Moncef Khairallah principal investigator
Monastir University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preoperative Intra-lesional Bevacizumab Injection in primary pterygium and pterygium surgery without adjunctive therapy in people with Pterygium, run by University Hospital Fattouma Bourguiba at 1 site in Tunisia.
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 1 inclusion and 2 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of recurrence (time frame: 6 months post-operatively). The study lists 2 primary outcomes in all. 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 6 Apr 2022.