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Effect of Intravitreal Bevacizumab on Corneal Endothelium

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ClinicalTrials.gov Identifier: NCT01726790
Recruitment Status : Unknown
Verified November 2012 by Kasem Yospaiboon, Khon Kaen University.
Recruitment status was:  Recruiting
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
Kasem Yospaiboon, Khon Kaen University

Brief Summary:
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

Condition or disease
Corneal Endothelial Cell Loss

Detailed Description:
Intravitreal Bevacizumab has been used by retinal specialist in treatment many retinal diseases. Although it not approved by FDA for treatment. In many In vitro studies, its showed saftey in the eyes especially for corneal endothelium cells, that important cells to keep cornea clear. This study use Confoscan-Corneal confocal microsope to evaluate corneal endothelium before and after intravitreal Bevacizumab injection in routine retinal disease at 6 month follow up.

Study Type : Observational
Estimated Enrollment : 37 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Intravitreal Bevacizumab on Corneal Endothelium
Study Start Date : August 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Corneal endothelium cell change after intravitreal Bevacizumab injection [ Time Frame: 6 months ]
    Measure the corneal endothelium cell using Confoscan4-Corneal confocal microscope in patient in retinal vascular clinic before and after treat with intravitreal Bevacizumab


Secondary Outcome Measures :
  1. Assess the complication after intravitreal Bevacizumab injection [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient in retinalvascular clinic with diagnosis of retinal vein occlusion with macular edema, diabetic macular edema, wet aged related macular degeneration and submacular hemorrhage)treated with intravitreal Bevacizumab
Criteria

Inclusion Criteria:

  • aged between 20 and 80 years old
  • can come to regular follow up at 6 month
  • signed written consent forms
  • not have corneal scar, or glaucoma
  • history of treatment with laser or anti-VEGF therapy in 3 month prior to recruit
  • high risk in cerebrovascular and cardiovascular diseases
  • Pregnancy and breastfeeding
  • can undergo confocal microspopy

Exclusion Criteria:

  • History of intraocular surgery or ocular trauma during study

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): NCT01726790


Contacts
Contact: Kasem Yospaiboon, MD 66823057231 kasem_yod@hotmail.com

Locations
Thailand
KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university Recruiting
Khon kaen, Thailand, 4002
Contact: Yosanan Yospaiboon, Professor    6643363010    yosanan@kku.ac.th   
Principal Investigator: Kasem Yospaiboon, MD         
Sponsors and Collaborators
Khon Kaen University

Responsible Party: Kasem Yospaiboon, Kasem Yospaiboon, MD, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01726790     History of Changes
Other Study ID Numbers: HE541020
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Kasem Yospaiboon, Khon Kaen University:
corneal endothelium
Bevacizumab
Intravitreal injection
Confoscan

Additional relevant MeSH terms:
Corneal Endothelial Cell Loss
Corneal Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents