Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

This study has been completed.
Sponsor:
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01288404
First received: February 1, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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


Condition Intervention
Pterygium of the Conjunctiva and Cornea
Drug: Fluorometholone
Drug: Bevacizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • Severity of impending recurrent pterygium [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analog scales [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse reactions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2008
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
topical 0.1% fluorometholone eye drops
Drug: Fluorometholone
topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks
Other Name: FML eye drops
Active Comparator: Bevacizumab group 1
Bevacizumab 1.25 mg/0.05mL
Drug: Bevacizumab
subconjunctival bevacizumab 1.25 mg/0.05mL
Other Name: Avastin
Active Comparator: Bevacizumab group 2
Bevacizumab 2.5 mg/0.1mL
Drug: Bevacizumab
subconjunctival bevacizumab 2.5 mg/0.1mL
Other Name: Avastin
Active Comparator: bevacizumab group 3
bevacizumab 3.75 mg/0.15mL
Drug: Bevacizumab
subconjunctival bevacizumab 3.75 mg/0.15mL
Other Name: Avastin

Detailed Description:
  1. Impending recurrent pterygium
  2. Anti-VEGF therapy

    • Bevacizumab
    • Subconjunctival injection
    • Suppress neovascularization
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288404

Locations
Thailand
Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
Principal Investigator: Kaevalin Lekhanont, MD Ramathibodi Hospital
  More Information

No publications provided

Responsible Party: Kaevalin Lekhanont, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01288404     History of Changes
Other Study ID Numbers: 055217
Study First Received: February 1, 2011
Last Updated: February 1, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:
Bevacizumab, impending recurrent pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Tetrahydrozoline
Fluorometholone
Bevacizumab
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014