Optic Nerve and Retinal Functions With Bevacizumab

Choroidal Neovascular Membrane Clinical Trial

Official title:

Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361828
• Other study ID #: Beva-ERG-VEP
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: May 26, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: January 2010
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: EGYPT: Department of Ophthalmology Cairo University
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 62 Years

Eligibility

Inclusion Criteria:

• CNV

Exclusion Criteria:

• Previous Intravitreal Injections

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Choroidal Neovascular Membrane

Intervention

Procedure:
• Electrophysiology
Visual Evoked Potential and Elctroretinogram

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	--- Select One ---

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Evoked Potential and Electroretinogram	VEP and ERG baseline and at 1 and 4 weeks post intravitreal injection of bevacizumab.	4 weeks	Yes

External Links

•   Electrophysiological assessment of retinal function during 6 months of bevacizumab treatment in neovascular age-related macular degeneration.