Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Pterygium of the Conjunctiva and Cornea Clinical Trial

Official title:

A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288404
• Other study ID #: 055217
• Status: Completed
• Phase: N/A
• First received: February 1, 2011
• Last updated: February 1, 2011
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

1. Impending recurrent pterygium

2. Anti-VEGF therapy

• Bevacizumab

• Subconjunctival injection

• Suppress neovascularization

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium
• Pterygium of the Conjunctiva and Cornea

Intervention

Drug:
• Fluorometholone
topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks
• Bevacizumab
subconjunctival bevacizumab 1.25 mg/0.05mL
• Bevacizumab
subconjunctival bevacizumab 2.5 mg/0.1mL
• Bevacizumab
subconjunctival bevacizumab 3.75 mg/0.15mL

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of impending recurrent pterygium		3 months	No
Secondary	Visual analog scales		3 months	No
Secondary	Adverse reactions		3 months	Yes