ERG/EOG Study in AMD Patients Treated With Ranibizumab

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retina Center, Minnesota
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

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