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

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ClinicalTrials.gov Identifier: NCT00791427
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Abdhish R. Bhavsar, M.D., Retina Center, Minnesota

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Drug: Ranibizumab

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Study Start Date : November 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
AMD Patients Drug: Ranibizumab
0.05 ml of ranibizumab injected into the eye monthly for one year


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
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
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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
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United States, Minnesota
The Retina Center
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Retina Center, Minnesota
Genentech, Inc.
More Information
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Additional Information:

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Responsible Party: Abdhish R. Bhavsar, M.D., President/Physician/Owner, Retina Center, Minnesota
ClinicalTrials.gov Identifier: NCT00791427    
Other Study ID Numbers: FVF4154s
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents