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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Retina Center, Minnesota.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Retina Center, Minnesota
ClinicalTrials.gov Identifier:
NCT00791427
First received: November 13, 2008
Last updated: July 21, 2011
Last verified: July 2011
  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

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

Resource links provided by NLM:


Further study details as provided by Retina Center, Minnesota:

Primary Outcome Measures:
  • ERG/EOG [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
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: NCT00791427

Locations
United States, Minnesota
The Retina Center
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Retina Center, Minnesota
Genentech
  More Information

Additional Information:
No publications provided

Responsible Party: Abdhish Bhavsar, MD PI, Retina Center, Minnesota
ClinicalTrials.gov Identifier: NCT00791427     History of Changes
Other Study ID Numbers: FVF4154s
Study First Received: November 13, 2008
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014