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A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678872
Recruitment Status : Active, not recruiting
First Posted : September 5, 2012
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Oxford BioMedica

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date October 2, 2019
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date March 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
The incidence of adverse events [ Time Frame: 15 years ]
The number of subjects with treatment emergent adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
The change from baseline in BCVA. [ Time Frame: 15 years ]
The change from baseline in Best Corrective Visual Acuity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Official Title  ICMJE A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE Drug: RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study
Study Arms  ICMJE Long Term Follow up
Long Term follow up of patients who received RetinoStat in a previous study.
Intervention: Drug: RetinoStat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2012)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2029
Estimated Primary Completion Date March 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have received a subretinal injection of RetinoStat
  • Must have been enrolled in Protocol RS1/001/10

Exclusion Criteria:

  • Did not receive RetinoStat® as part of the RS1/001/10 protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678872
Other Study ID Numbers  ICMJE RS1/002/11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oxford BioMedica
Study Sponsor  ICMJE Oxford BioMedica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Campochiaro, MD John Hopkins University Hospital
PRS Account Oxford BioMedica
Verification Date October 2019

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