ERG/EOG Study in AMD Patients Treated With Ranibizumab (FVF4154s)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Retina Center, Minnesota.
Recruitment status was Active, not recruiting
Information provided by:
Retina Center, Minnesota
First received: November 13, 2008
Last updated: July 21, 2011
Last verified: July 2011
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.
Age-Related Macular Degeneration
||Observational Model: Case-Only
Time Perspective: Prospective
||ERG/EOG Study in AMD Patients Treated With Ranibizumab
Primary Outcome Measures:
- ERG/EOG [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
0.05 ml of ranibizumab injected into the eye monthly for one year
|Ages Eligible for Study:
||55 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients will have AMD with choroidal neovascularization and above age 55 years.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791427
|The Retina Center
|Minneapolis, Minnesota, United States, 55404 |
Retina Center, Minnesota
No publications provided
||Abdhish Bhavsar, MD PI, Retina Center, Minnesota
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 13, 2008
||July 21, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 22, 2014