Effect of Intravitreal Bevacizumab on Corneal Endothelium

Corneal Endothelial Cell Loss Clinical Trial

Official title:

Effect of Intravitreal Bevacizumab on Corneal Endothelium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726790
• Other study ID #: HE541020
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2012
• Last updated: November 11, 2012
• Start date: August 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2012
• Source: Khon Kaen University
• Contact: Kasem Yospaiboon, MD
• Phone: 66823057231
• Email: kasem_yod[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Observational

Clinical Trial Summary

To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Endothelial Cell Loss

Locations

Country	Name	City	State
Thailand	KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university	Khon kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelium cell change after intravitreal Bevacizumab injection	Measure the corneal endothelium cell using Confoscan4-Corneal confocal microscope in patient in retinal vascular clinic before and after treat with intravitreal Bevacizumab	6 months	Yes
Secondary	Assess the complication after intravitreal Bevacizumab injection		6 month	Yes