- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361828
Optic Nerve and Retinal Functions With Bevacizumab
May 26, 2011 updated by: Cairo University
Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).
The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal in human eyes using electrophysiological tests; Electroretinogram (ERG) and Visual Evoked Potentials (VEP).
Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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--- Select One ---
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Cairo, --- Select One ---, Egypt, 11421
- Cairo University
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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
24 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.Mean age was 50 years ranging from 24-62 years with 25 females, with 28 AMD and 17 myopic patients.
Description
Inclusion Criteria:
- CNV
Exclusion Criteria:
- Previous Intravitreal Injections
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with choroidal neovascularization
CNV due to Age-Related Macular Degenerations and Myopia were included.
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Visual Evoked Potential and Elctroretinogram
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Evoked Potential and Electroretinogram
Time Frame: 4 weeks
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VEP and ERG baseline and at 1 and 4 weeks post intravitreal injection of bevacizumab.
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tamer A macky, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
May 26, 2011
First Submitted That Met QC Criteria
May 26, 2011
First Posted (Estimate)
May 27, 2011
Study Record Updates
Last Update Posted (Estimate)
May 27, 2011
Last Update Submitted That Met QC Criteria
May 26, 2011
Last Verified
January 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- Beva-ERG-VEP
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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