ERG/EOG Study in AMD Patients Treated With Ranibizumab - Full Text View

ERG/EOG Study in AMD Patients Treated With Ranibizumab (FVF4154s)

This study is currently recruiting participants.

Verified by Retina Center, Minnesota, November 2008

Sponsors and Collaborators:	Retina Center, Minnesota Genentech
Information provided by:	Retina Center, Minnesota
ClinicalTrials.gov Identifier:	NCT00791427

Purpose

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.

Condition	Intervention
Age-Related Macular Degeneration	Drug: Ranibizumab

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	ERG/EOG Study in AMD Patients Treated With Ranibizumab

Further study details as provided by Retina Center, Minnesota:

Primary Outcome Measures:

ERG/EOG [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10
Study Start Date:	November 2008

Groups/Cohorts	Assigned Interventions
AMD Patients	Drug: Ranibizumab 0.05 ml of ranibizumab injected into the eye monthly for one year

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

PAtients will have AMD with choroidal neovascularization and above age 55 years.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791427

Locations

United States, Minnesota
The Retina Center	Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Vu T Huynh, MPH 612-746-3880 vu@retinadocs.com

Sponsors and Collaborators

Retina Center, Minnesota

Genentech

More Information

facility website This link exits the ClinicalTrials.gov site

Responsible Party:	Retina Center, Minnesota ( Abdhish Bhavsar, MD PI )
Study ID Numbers:	FVF4154s
Study First Received:	November 13, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00791427
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009