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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

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 7, 2012
Last Update Posted Date December 7, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
Pterygium size after subconjunctival bevacizumab [ Time Frame: 8 weeks ]
-Size of recurrent pterygium (measured in mm) after injection
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subconjunctival Bevacizumab and Recurrent Pterygium
Official Title  ICMJE Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
Brief Summary A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.
Detailed Description
  1. Pacients with recurrent pterygium
  2. Anti-VEGF therapy -Bevacizumab
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Pterygium
Intervention  ICMJE Drug: Bevacizumab
One subconjunctival aplication of Bevacizumabe 0,5ml
Other Name: Avastin
Study Arms  ICMJE Experimental: Subconjunctival Bevacizumab
One aplication of subconjunctival Bevacizumab 0,5 ml
Intervention: Drug: Bevacizumab
Publications * Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2012)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recurrent pterygium

Exclusion Criteria:

  • Pregnant or lactating women
  • History of myocardial infarction
  • History of stroke
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744756
Other Study ID Numbers  ICMJE pterygium bevacizumab
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Olhos de Goiania
Study Sponsor  ICMJE Instituto de Olhos de Goiania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Larissa S Stival, MD Instituto de Olhos de Goiania
PRS Account Instituto de Olhos de Goiania
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP