Optic Nerve and Retinal Functions With Bevacizumab

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01361828
First received: May 26, 2011
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention
Choroidal Neovascular Membrane
Procedure: Electrophysiology

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).

Resource links provided by NLM:


Further study details as provided by Cairo University:

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


Enrollment: 45
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with choroidal neovascularization
CNV due to Age-Related Macular Degenerations and Myopia were included.
Procedure: Electrophysiology
Visual Evoked Potential and Elctroretinogram

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.

  Eligibility

Ages Eligible for Study:   24 Years to 62 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361828

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

Additional Information:
No publications provided

Responsible Party: Tamer A Macky, Cario University
ClinicalTrials.gov Identifier: NCT01361828     History of Changes
Other Study ID Numbers: Beva-ERG-VEP
Study First Received: May 26, 2011
Last Updated: May 26, 2011
Health Authority: EGYPT: Department of Ophthalmology Cairo University

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

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014