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

Retina Center, Minnesota

Status: Completed

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Ranibizumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00791427

FVF4154s

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

AMD Patients

Treatment:

Drug: Ranibizumab