ERG/EOG Study in AMD Patients Treated With Ranibizumab

Age-Related Macular Degeneration Clinical Trial

— FVF4154s  

Official title:

ERG/EOG Study in AMD Patients Treated With Ranibizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791427
• Other study ID #: FVF4154s
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: May 7, 2015
• Start date: November 2008
• Est. completion date: September 2011

Study information

• Verified date: May 2015
• Source: Retina Center, Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age >55 years

• Patients to be included in the study must have AMD with choroidal neovascularization

• BCVA between 20/20 - 20/400

• Lesion size less than or equal to 12 MPS disc areas

Exclusion Criteria:

• Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study

• Pregnancy (positive pregnancy test)

• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch

• Prior enrollment in the study

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

• Media insufficient to obtain a view

• Other causes of CNV not related to AMD

• Active ocular or peri-ocular infection

• Ocular surgery within 1 month prior to the study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Ranibizumab
0.05 ml of ranibizumab injected into the eye monthly for one year

Locations

Country	Name	City	State
United States	The Retina Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Retina Center, Minnesota	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ERG/EOG		1 year	No

External Links

•   facility website