NCT01361828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
Last Updated

May 27, 2011

Status Verified

January 1, 2010

Enrollment Period

6 months

First QC Date

May 26, 2011

Last Update Submit

May 26, 2011

Conditions

Keywords

BevacizumabVEPERGOptic nerve and retinal functions following intravitreal bevacizumab

Outcome Measures

Primary Outcomes (1)

  • Visual Evoked Potential and Electroretinogram

    VEP and ERG baseline and at 1 and 4 weeks post intravitreal injection of bevacizumab.

    4 weeks

Study Arms (1)

Patients with choroidal neovascularization

CNV due to Age-Related Macular Degenerations and Myopia were included.

Procedure: Electrophysiology

Interventions

Visual Evoked Potential and Elctroretinogram

Patients with choroidal neovascularization

Eligibility Criteria

Age24 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • CNV

You may not qualify if:

  • Previous Intravitreal Injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, --- Select One ---, 11421, Egypt

Location

Related Links

Study Officials

  • Tamer A macky

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2011

First Posted

May 27, 2011

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 27, 2011

Record last verified: 2010-01

Locations