drugset / Trial / NCT05314673

Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients

NCT05314673

Phase 4 Completed 60 enrolled University Hospital Fattouma Bourguiba
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-01-01
Primary completion
2021-01-01
Completion
2021-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 1.25 mg Other