Effect of Intravitreal Bevacizumab on Corneal Endothelium

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Khon Kaen University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Kasem Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
First received: November 11, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

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:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726790

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

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

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
Intravitreal injection

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

ClinicalTrials.gov processed this record on May 26, 2016