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

Phase 1

Active, not recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: RetinoStat

• Registration Number: NCT01678872
• Lead Sponsor: Oxford BioMedica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long Term Follow up	RetinoStat	Long Term follow up of patients who received RetinoStat in a previous study.

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events	14 years	The number of subjects with treatment emergent adverse events.

Secondary Outcome Measures

Name	Time	Method
The change from baseline in BCVA.	14 years	The change from baseline in Best Corrective Visual Acuity.

Trial Locations

Locations (3)

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States

John Hopkins University Hospital; 🇺🇸 Baltimore, Maryland, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States