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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.
Information provided by (Responsible Party):
Oxford BioMedica Identifier:
First received: August 31, 2012
Last updated: May 28, 2014
Last verified: May 2014
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: 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 ]
    The number of subjects with treatment emergent adverse events.

Secondary Outcome Measures:
  • The change from baseline in BCVA. [ Time Frame: 15 years ]
    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


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

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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Please refer to this study by its identifier: NCT01678872

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
Principal Investigator: Peter Campochiaro, MD John Hopkins University Hospital
  More Information

Responsible Party: Oxford BioMedica Identifier: NCT01678872     History of Changes
Other Study ID Numbers: RS1/002/11
Study First Received: August 31, 2012
Last Updated: May 28, 2014

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on May 25, 2017