ERG/EOG Study in AMD Patients Treated With Ranibizumab

Overview

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

Interventions

  • 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

  • ERG/EOG
    • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.