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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791427
First Posted: November 14, 2008
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Abdhish R. Bhavsar, M.D., Retina Center, Minnesota
  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 Abdhish R. Bhavsar, M.D., Retina Center, Minnesota:

Primary Outcome Measures:
  • ERG/EOG [ Time Frame: 1 year ]

Enrollment: 10
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AMD Patients Drug: Ranibizumab
0.05 ml of ranibizumab injected into the eye monthly for one year

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791427


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

Additional Information:
Responsible Party: Abdhish R. Bhavsar, M.D., President/Physician/Owner, Retina Center, Minnesota
ClinicalTrials.gov Identifier: NCT00791427     History of Changes
Other Study ID Numbers: FVF4154s
First Submitted: November 13, 2008
First Posted: November 14, 2008
Last Update Posted: May 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents