Clinical trial

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

Name

RS1/002/11

Description

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.

Trial arms

Trial start

2012-08-01

Estimated PCD

2029-03-01

Trial end

2029-03-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

RetinoStat

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

Arms:

Long Term Follow up

Size

Primary endpoint

The incidence of adverse events

14 years

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

Updated at

2024-04-15

1 organization

1 product

1 indication

Organization

Oxford Biomedica

Product

RetinoStat

Indication

Age-related macular degeneration