Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients

NCT05314673 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: LR18SP09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium

Keywords

pterygium; bevacizumab; recurrence; Vascularity; subconjunctival

Outcome Measures

Primary Outcomes (2)

• Incidence of recurrence

  growth of fibrovascular tissue extending more than 1 mm across the limbus.

  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)).

  6 months post-operatively

Secondary Outcomes (3)

• Rate of mean changes from baseline in BCSVA

  6 months post-operatively

• Rate of mean changes from baseline in astigmatism

  6 months post-operatively

• % of patients with change in morphology of pterygium after injection

  one month

Study Arms (2)

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.

Drug: Preoperative Intra-lesional Bevacizumab Injection in primary pterygium

pterygium excision+ autograft

ACTIVE COMPARATOR

Patients undergoing only pterygium surgical treatment.

Procedure: pterygium surgery without adjunctive therapy

Interventions

Preoperative Intra-lesional Bevacizumab Injection in primary pterygium DRUG

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.

Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft

pterygium surgery without adjunctive therapy PROCEDURE

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

pterygium excision+ autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.

You may not qualify if:

• unable to attend the whole follow-up
• Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).

Sponsors & Collaborators

• University Hospital Fattouma Bourguiba: lead

Study Sites (1)

Dhouha Gouider

Aryanah, Illinois, 2037, Tunisia

Location

MeSH Terms

Conditions

Pterygium; Recurrence

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moncef Khairallah

  Monastir University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 6, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: They are available

Locations

TU (1)