A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: August 31, 2012
Last updated: February 22, 2014
Last verified: September 2013
The purpose of this study is to examine the long term safety of an experimental gene transfer agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Oxford BioMedica:
Primary Outcome Measures:
- The incidence of adverse events [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]The number of subjects with treatment emergent adverse events.
Secondary Outcome Measures:
- The change from baseline in BCVA. [ Time Frame: 15 years ] [ Designated as safety issue: No ]The change from baseline in Best Corrective Visual Acuity.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||November 2027|
|Estimated Primary Completion Date:||November 2027 (Final data collection date for primary outcome measure)|
Long Term Follow up
Long Term follow up of patients who received RetinoStat in a previous study.
Long Term Follow up of patients who received RetinoStat in a previous study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678872
|United States, Maryland|
|John Hopkins University Hospital|
|Baltimore, Maryland, United States, 21287-9277|
Sponsors and Collaborators
|Principal Investigator:||Peter Campochiaro, MD||John Hopkins University Hospital|