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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RetinoStat

Drug

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

Primary outcomes

The incidence of adverse events

Time frame: 14 years

The number of subjects with treatment emergent adverse events.

Secondary outcomes

The change from baseline in BCVA.

Time frame: 14 years

The change from baseline in Best Corrective Visual Acuity.

Sponsors and collaborators

Lead sponsor

Oxford BioMedica

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2029
Study completion: 2029
First posted: Sep 5, 2012
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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