Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

NCT01288404 | Completed

• 1 other identifier: 055217
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pterygium of the Conjunctiva and Cornea

Keywords

Bevacizumab, impending recurrent pterygium

Outcome Measures

Primary Outcomes (1)

• Severity of impending recurrent pterygium

  3 months

Secondary Outcomes (2)

• Visual analog scales

  3 months

• Adverse reactions

  3 months

Study Arms (4)

Control

PLACEBO COMPARATOR

topical 0.1% fluorometholone eye drops

Drug: Fluorometholone

Bevacizumab group 1

ACTIVE COMPARATOR

Bevacizumab 1.25 mg/0.05mL

Drug: Bevacizumab

Bevacizumab group 2

ACTIVE COMPARATOR

Bevacizumab 2.5 mg/0.1mL

Drug: Bevacizumab

bevacizumab group 3

ACTIVE COMPARATOR

bevacizumab 3.75 mg/0.15mL

Drug: Bevacizumab

Interventions

Fluorometholone DRUG

topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks

Also known as: FML eye drops

Control

Bevacizumab DRUG

subconjunctival bevacizumab 1.25 mg/0.05mL

Also known as: Avastin

Bevacizumab group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Platelet disorders
• Hypertension
• Pregnant or lactating women

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

Fluorometholone; Bevacizumab

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kaevalin Lekhanont, MD

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 2, 2011

Record last verified: 2011-01

Locations

TH (1)