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Optic Nerve and Retinal Functions With Bevacizumab

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ClinicalTrials.gov Identifier: NCT01361828
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : May 27, 2011
Sponsor:
Information provided by:
Cairo University

Brief Summary:
The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes.

Condition or disease Intervention/treatment
Choroidal Neovascular Membrane Procedure: Electrophysiology

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
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).
Study Start Date : January 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Bevacizumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with choroidal neovascularization
CNV due to Age-Related Macular Degenerations and Myopia were included.
Procedure: Electrophysiology
Visual Evoked Potential and Elctroretinogram



Primary Outcome Measures :
  1. Visual Evoked Potential and Electroretinogram [ Time Frame: 4 weeks ]
    VEP and ERG baseline and at 1 and 4 weeks post intravitreal injection of bevacizumab.



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Ages Eligible for Study:   24 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • CNV

Exclusion Criteria:

  • Previous Intravitreal Injections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361828


Locations
Egypt
Cairo University
Cairo, --- Select One ---, Egypt, 11421
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Tamer A macky Cairo University

Additional Information:
Responsible Party: Tamer A Macky, Cario University
ClinicalTrials.gov Identifier: NCT01361828     History of Changes
Other Study ID Numbers: Beva-ERG-VEP
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: January 2010

Keywords provided by Cairo University:
Bevacizumab
VEP
ERG
Optic nerve and retinal functions following intravitreal bevacizumab

Additional relevant MeSH terms:
Retinal Neovascularization
Retinal Diseases
Eye Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents