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
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Drug: RetinoStat
Phase 1

Study Type: Interventional
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:


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.


Estimated Enrollment: 18
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678872

Locations
United States, Maryland
John Hopkins University Hospital
Baltimore, Maryland, United States, 21287-9277
Sponsors and Collaborators
Oxford BioMedica
Investigators
Principal Investigator: Peter Campochiaro, MD John Hopkins University Hospital
  More Information

No publications provided

Responsible Party: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT01678872     History of Changes
Other Study ID Numbers: RS1/002/11
Study First Received: August 31, 2012
Last Updated: February 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014