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NCT01678872 Clinical Trial

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

Age-Related Macular Degeneration Clinical Trial

Official title:
A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01678872
Other study ID # RS1/002/11
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date August 2012
Est. completion date March 2029

Study information
Verified date April 2024
Source Oxford BioMedica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 18
Est. completion date March 2029
Est. primary completion date March 2029
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study

Locations
Country Name City State
United States John Hopkins University Hospital Baltimore Maryland
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oxford BioMedica

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse events The number of subjects with treatment emergent adverse events. 14 years
Secondary The change from baseline in BCVA. The change from baseline in Best Corrective Visual Acuity. 14 years
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