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Subconjunctival Bevacizumab and Recurrent Pterygium (BRP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT01744756
First received: November 29, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Recurrent Pterygium
 Drug: Bevacizumab
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Instituto de Olhos de Goiania:

Primary Outcome Measures:
  • Pterygium size after subconjunctival bevacizumab [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    -Size of recurrent pterygium (measured in mm) after injection


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


Enrollment: 36
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subconjunctival Bevacizumab
One aplication of subconjunctival Bevacizumab 0,5 ml
 Drug: Bevacizumab
One subconjunctival aplication of Bevacizumabe 0,5ml
Other Name: Avastin

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent pterygium

Exclusion Criteria:

  • Pregnant or lactating women
  • History of myocardial infarction
  • History of stroke
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744756

Locations
Brazil
Instituto de Olhos de Goiania
Goiania, Goias, Brazil, 74110120
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: Larissa S Stival, MD Instituto de Olhos de Goiania
  More Information

No publications provided

Responsible Party: Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT01744756     History of Changes
Other Study ID Numbers: pterygium bevacizumab
Study First Received: November 29, 2012
Last Updated: December 6, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Instituto de Olhos de Goiania:
Subconjunctival Bevacizumab
Recurrent pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013