Corneal Endothelial Cell LossNCT01726790
Effect of Intravitreal Bevacizumab on Corneal Endothelium
An observational study of Corneal Endothelial Cell Loss, run by Khon Kaen University at 1 site in Thailand.
Trial summary
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Endothelial Cell Loss
- How many people
- 37 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- History of intraocular surgery or ocular trauma during study
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university
Khon Kaen, Changwat Khon Kaen, 4002
Yosanan Yospaiboon, Professor, 6643363010, yosanan@kku.ac.th
Kasem Yospaiboon, MD
About this study
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection
Read the 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.
- Conditions
- Corneal Endothelial Cell Loss
- Keywords
- corneal endothelium, Bevacizumab, Intravitreal injection, Confoscan
- Medical subject headings
- Corneal Endothelial Cell Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Assess the complication after intravitreal Bevacizumab injection
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasem Yospaiboon, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726790
- Sponsor's protocol ID
- HE541020
- Status last verified
- Nov 2012
- First submitted
- 11 Nov 2012
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Bevacizumab on Corneal Endothelium
- ClinicalTrials.gov ID
- NCT01726790
- Acronym / sponsor ID
- HE541020
- Conditions
- Corneal Endothelial Cell Loss
- Keywords
- corneal endothelium, Bevacizumab, Intravitreal injection, Confoscan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- History of intraocular surgery or ocular trauma during study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Assess the complication after intravitreal Bevacizumab injection
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Endothelial Cell Loss, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasem Yospaiboon, MD (66823057231, kasem_yod@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal endothelium cell change after intravitreal Bevacizumab injection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.