Effect of Intravitreal Bevacizumab on Corneal Endothelium

November 11, 2012 updated by: Kasem Yospaiboon, Khon Kaen University
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Khon kaen, Thailand, 4002
        • Recruiting
        • KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university
        • Contact:
        • Principal Investigator:
          • Kasem Yospaiboon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the complication after intravitreal Bevacizumab injection
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

October 1, 2013

Study Registration Dates

First Submitted

November 11, 2012

First Submitted That Met QC Criteria

November 11, 2012

First Posted (ESTIMATE)

November 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 11, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE541020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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