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.
Sponsor:
Information provided by (Responsible Party):
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01678872
First received: August 31, 2012
Last updated: February 22, 2014
Last verified: September 2013

August 31, 2012
February 22, 2014
August 2012
November 2027   (final data collection date for primary outcome measure)
The incidence of adverse events [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
The number of subjects with treatment emergent adverse events.
Same as current
Complete list of historical versions of study NCT01678872 on ClinicalTrials.gov Archive Site
The change from baseline in BCVA. [ Time Frame: 15 years ] [ Designated as safety issue: No ]
The change from baseline in Best Corrective Visual Acuity.
Same as current
Not Provided
Not Provided
 
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Age-Related Macular Degeneration
Drug: RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study
Long Term Follow up
Long Term follow up of patients who received RetinoStat in a previous study.
Intervention: Drug: RetinoStat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
18
November 2027
November 2027   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have received a subretinal injection of RetinoStat
  • Must have completed protocol RS1/001/10 to week 48 or undergone an early discontinuation visit.

Exclusion Criteria:

  • Did not receive RetinoStat® as part of the RS1/001/10 protocol
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01678872
RS1/002/11
Yes
Oxford BioMedica
Oxford BioMedica
Not Provided
Principal Investigator: Peter Campochiaro, MD John Hopkins University Hospital
Oxford BioMedica
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP