ERG/EOG Study in AMD Patients Treated With Ranibizumab


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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2011


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

Arms, Groups and Cohorts

  • AMD Patients

Clinical Trial Outcome Measures

Primary Measures

    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Retina Center, Minnesota
  • Collaborator
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Abdhish R. Bhavsar, M.D., President/Physician/Owner – Retina Center, Minnesota

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