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Subconjunctival Bevacizumab and Recurrent Pterygium (BRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744756
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : December 7, 2012
Sponsor:
Information provided by (Responsible Party):
Instituto de Olhos de Goiania

Brief Summary:
A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

Condition or disease Intervention/treatment Phase
Recurrent Pterygium Drug: Bevacizumab Phase 2 Phase 3

Detailed Description:
  1. Pacients with recurrent pterygium
  2. Anti-VEGF therapy -Bevacizumab

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Subconjunctival Bevacizumab
One aplication of subconjunctival Bevacizumab 0,5 ml
Drug: Bevacizumab
One subconjunctival aplication of Bevacizumabe 0,5ml
Other Name: Avastin




Primary Outcome Measures :
  1. Pterygium size after subconjunctival bevacizumab [ Time Frame: 8 weeks ]
    -Size of recurrent pterygium (measured in mm) after injection


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]
    -Number of patients with hyposphagma and irritative symptoms after subconjunctival injection



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent pterygium

Exclusion Criteria:

  • Pregnant or lactating women
  • History of myocardial infarction
  • History of stroke

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): NCT01744756


Locations
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Brazil
Instituto de Olhos de Goiania
Goiania, Goias, Brazil, 74110120
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
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Study Chair: Larissa S Stival, MD Instituto de Olhos de Goiania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT01744756    
Other Study ID Numbers: pterygium bevacizumab
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012
Keywords provided by Instituto de Olhos de Goiania:
Subconjunctival Bevacizumab
Recurrent pterygium
Additional relevant MeSH terms:
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Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors