A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration

Sponsor
Oxford BioMedica (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01678872
Collaborator
(none)
18
3
1
199
6
0

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2029
Anticipated Study Completion Date :
Mar 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. The incidence of adverse events [15 years]

    The number of subjects with treatment emergent adverse events.

Secondary Outcome Measures

  1. The change from baseline in BCVA. [15 years]

    The change from baseline in Best Corrective Visual Acuity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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

Locations

Site City State Country Postal Code
1 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52245
2 John Hopkins University Hospital Baltimore Maryland United States 21287-9277
3 Oregon Health & Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • Oxford BioMedica

Investigators

  • Principal Investigator: Peter Campochiaro, MD, John Hopkins University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01678872
Other Study ID Numbers:
  • RS1/002/11
First Posted:
Sep 5, 2012
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2021