ERG/EOG Study in AMD Patients Treated With Ranibizumab

NCT00791427 | Completed

• 1 other identifier: FVF4154s
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• ERG/EOG

  1 year

Study Arms (1)

AMD Patients

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

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

AMD Patients

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will have AMD with choroidal neovascularization and above age 55 years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Center, Minnesota: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Retina Center

Minneapolis, Minnesota, 55404, United States

Location

Related Links

• facility website

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President/Physician/Owner

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)