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: May 28, 2014
Last verified: May 2014
  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: 21
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 been enrolled in Protocol RS1/001/10

Exclusion Criteria:

  • Did not receive RetinoStat® as part of the RS1/001/10 protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
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: May 28, 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 July 10, 2014