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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01678872

Enrollment

Registered

2012-09-05

Start date

2012-08-31

Completion date

2029-03-31

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

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.

Interventions

DRUGRetinoStat

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of adverse events	14 years	The number of subjects with treatment emergent adverse events.

Secondary

Measure	Time frame	Description
The change from baseline in BCVA.	14 years	The change from baseline in Best Corrective Visual Acuity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026