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Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

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ClinicalTrials.gov Identifier: NCT01288404
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : February 2, 2011
Sponsor:
Information provided by:
Ramathibodi Hospital

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

Condition or disease Intervention/treatment Phase
Pterygium of the Conjunctiva and Cornea Drug: Fluorometholone Drug: Bevacizumab Not Applicable

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

    • Bevacizumab
    • Subconjunctival injection
    • Suppress neovascularization

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Study Start Date : January 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Severity of impending recurrent pterygium [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visual analog scales [ Time Frame: 3 months ]
  2. Adverse reactions [ Time Frame: 3 months ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288404


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

Responsible Party: Kaevalin Lekhanont, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01288404     History of Changes
Other Study ID Numbers: 055217
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: January 2011

Keywords provided by Ramathibodi Hospital:
Bevacizumab, impending recurrent pterygium

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