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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 12, 2020
Sponsor:
Information provided by (Responsible Party):
Oxford BioMedica

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: RetinoStat Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Study Start Date : August 2012
Estimated Primary Completion Date : March 2029
Estimated Study Completion Date : March 2029

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Arms and Interventions
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Arm Intervention/treatment
Long Term Follow up
Long Term follow up of patients who received RetinoStat in a previous study.
 Drug: RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: 15 years ]
    The number of subjects with treatment emergent adverse events.


Secondary Outcome Measures :
  1. The change from baseline in BCVA. [ Time Frame: 15 years ]
    The change from baseline in Best Corrective Visual Acuity.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678872


Locations
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United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52245
United States, Maryland
John Hopkins University Hospital
Baltimore, Maryland, United States, 21287-9277
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oxford BioMedica
Investigators
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Principal Investigator: Peter Campochiaro, MD John Hopkins University Hospital
More Information
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Responsible Party: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT01678872    
Other Study ID Numbers: RS1/002/11
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases