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Completed

NCT Number: NCT00791427

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Retina Center

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

0.05 ml of ranibizumab injected into the eye monthly for one year

Primary outcomes

  1. ERG/EOG

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Retina Center, Minnesota

Other

Collaborators

  • Genentech, Inc.

Registry information

Acronym: FVF4154s

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 14, 2008
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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