Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Mahidol University

Status: Completed

Conditions: Pterygium of the Conjunctiva and Cornea

Treatments: Drug: Bevacizumab; Drug: Fluorometholone

Study type: Interventional

Funder types: Other

Identifiers

NCT01288404

055217

Details and patient eligibility

About

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

Full description

1. Impending recurrent pterygium

2. Anti-VEGF therapy

   • Bevacizumab
   • Subconjunctival injection
   • Suppress neovascularization

Enrollment: 80 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
2. 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.
3. No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
4. No other ocular surface pathologies or coexisting ocular diseases.
5. No other ocular surgeries within the previous 6 months.
6. No history of allergy to the medications used in this study.
7. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion criteria

1. Platelet disorders
2. Hypertension
3. Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

topical 0.1% fluorometholone eye drops

Treatment:

Drug: Fluorometholone

Bevacizumab group 1

Active Comparator group

Description:

Bevacizumab 1.25 mg/0.05mL

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Bevacizumab

Bevacizumab group 2

Active Comparator group

Description:

Bevacizumab 2.5 mg/0.1mL

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Bevacizumab

bevacizumab group 3

Active Comparator group

Description:

bevacizumab 3.75 mg/0.15mL

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Bevacizumab