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Effect of Intravitreal Bevacizumab on Corneal Endothelium

This study is currently recruiting participants.
Verified November 2012 by Khon Kaen University
Sponsor:
Information provided by (Responsible Party):
Kasem Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01726790
First received: November 11, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection


Condition
Corneal Endothelial Cell Loss

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Intravitreal Bevacizumab on Corneal Endothelium

Resource links provided by NLM:

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

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Corneal endothelium cell change after intravitreal Bevacizumab injection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Assess the complication after intravitreal Bevacizumab injection [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kasem Yospaiboon, Kasem Yospaiboon, MD, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01726790     History of Changes
Other Study ID Numbers: HE541020
Study First Received: November 11, 2012
Last Updated: November 11, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by 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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013