Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Sponsor
Ramathibodi Hospital
Study ID
NCT01288404
Status
Completed

Conditions

  • Pterygium of the Conjunctiva and Cornea

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

First listed
Feb 2, 2011
Start date
Jan 31, 2008
Status verified
Jan 2011
Primary completion
Sep 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control
    topical 0.1% fluorometholone eye drops
  • Active Comparator: Bevacizumab group 1
    Bevacizumab 1.25 mg/0.05mL
  • Active Comparator: Bevacizumab group 2
    Bevacizumab 2.5 mg/0.1mL
  • Active Comparator: bevacizumab group 3
    bevacizumab 3.75 mg/0.15mL

Primary Outcome Measure

Severity of impending recurrent pterygium [ Time Frame: 3 months ]