We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01678872
First Posted: September 5, 2012
Last Update Posted: May 29, 2014
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.
Information provided by (Responsible Party):
Oxford BioMedica
  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: Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
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
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

Responsible Party: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT01678872     History of Changes
Other Study ID Numbers: RS1/002/11
First Submitted: August 31, 2012
First Posted: September 5, 2012
Last Update Posted: May 29, 2014
Last Verified: May 2014

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