Skip to content

ERG/EOG Study in AMD Patients Treated With Ranibizumab

ERG/EOG Study in AMD Patients Treated With Ranibizumab

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00791427
Acronym
FVF4154s
Enrollment
10
Registered
2008-11-14
Start date
2008-11-30
Completion date
2011-09-30
Last updated
2015-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Brief 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.

Interventions

DRUGRanibizumab

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

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
Retina Center, Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ERG/EOG1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026