Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients
Primary Purpose
Pterygium
Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Preoperative Intra-lesional Bevacizumab Injection in primary pterygium
pterygium surgery without adjunctive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium focused on measuring pterygium, bevacizumab, recurrence, Vascularity, subconjunctival
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.
Exclusion Criteria:
- unable to attend the whole follow-up
- Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).
Sites / Locations
- Dhouha Gouider
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft
pterygium excision+ autograft
Arm Description
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.
Patients undergoing only pterygium surgical treatment.
Outcomes
Primary Outcome Measures
Incidence of recurrence
growth of fibrovascular tissue extending more than 1 mm across the limbus.
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)).
Secondary Outcome Measures
Rate of mean changes from baseline in BCSVA
one Snellen line
Rate of mean changes from baseline in astigmatism
Astigmatism change > 0.25
% 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).
Full Information
NCT ID
NCT05314673
First Posted
February 28, 2022
Last Updated
April 3, 2022
Sponsor
University Hospital Fattouma Bourguiba
1. Study Identification
Unique Protocol Identification Number
NCT05314673
Brief Title
Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients
Official Title
Preoperative Intra-lesional Bevacizumab Injection in Primary Pterygium in Tunisian Patients: A Randomized Controlled Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Fattouma Bourguiba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
pterygium, bevacizumab, recurrence, Vascularity, subconjunctival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft
Arm Type
Active Comparator
Arm Description
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.
Arm Title
pterygium excision+ autograft
Arm Type
Active Comparator
Arm Description
Patients undergoing only pterygium surgical treatment.
Intervention Type
Drug
Intervention Name(s)
Preoperative Intra-lesional Bevacizumab Injection in primary pterygium
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
pterygium surgery without adjunctive therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of recurrence
Description
growth of fibrovascular tissue extending more than 1 mm across the limbus.
Time Frame
6 months post-operatively
Title
Rate of functional discomfort following intralesional bevacizumab injection
Description
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)).
Time Frame
6 months post-operatively
Secondary Outcome Measure Information:
Title
Rate of mean changes from baseline in BCSVA
Description
one Snellen line
Time Frame
6 months post-operatively
Title
Rate of mean changes from baseline in astigmatism
Description
Astigmatism change > 0.25
Time Frame
6 months post-operatively
Title
% of patients with change in morphology of pterygium after injection
Description
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).
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.
Exclusion Criteria:
unable to attend the whole follow-up
Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moncef Khairallah
Organizational Affiliation
Monastir University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhouha Gouider
City
Ariana
State/Province
Illinois
ZIP/Postal Code
2037
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
They are available
Learn more about this trial
Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients
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