Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Study Overview
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Brief Summary
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Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.

Detailed Description
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Impending recurrent pterygium Anti-VEGF therapy Bevacizumab Subconjunctival injection Suppress neovascularization

Official Title
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A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Conditions
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Pterygium of the Conjunctiva and Cornea

Intervention / Treatment
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* Drug: Fluorometholone
* Drug: Bevacizumab
* Drug: Bevacizumab
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting. Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment. No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation. No other ocular surface pathologies or coexisting ocular diseases. No other ocular surgeries within the previous 6 months. No history of allergy to the medications used in this study. Good compliance with the study regimen and availability for the duration of the entire study period. Exclusion Criteria: Platelet disorders Hypertension Pregnant or lactating women
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>topical 0.1% fluorometholone eye drops | Drug: Fluorometholone<br>* topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks<br>* Other names: FML eye drops;|
| Active Comparator: Bevacizumab group 1<br>Bevacizumab 1.25 mg/0.05mL | Drug: Bevacizumab<br>* subconjunctival bevacizumab 1.25 mg/0.05mL<br>* Other names: Avastin;|
| Active Comparator: Bevacizumab group 2<br>Bevacizumab 2.5 mg/0.1mL | Drug: Bevacizumab<br>* subconjunctival bevacizumab 2.5 mg/0.1mL<br>* Other names: Avastin;|
| Active Comparator: bevacizumab group 3<br>bevacizumab 3.75 mg/0.15mL | Drug: Bevacizumab<br>* subconjunctival bevacizumab 3.75 mg/0.15mL<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of impending recurrent pterygium |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scales |  | 3 months | 
| Adverse reactions |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bevacizumab, impending recurrent pterygium