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Gene Transfer Agent

RetinoStat® Safety for Age-Related Macular Degeneration

Phase 1
Waitlist Available
Led By Peter Campochiaro, MD
Research Sponsored by Oxford BioMedica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have received a subretinal injection of RetinoStat
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the long-term safety of a new gene therapy for age-related macular degeneration.

Who is the study for?
This trial is specifically for patients who were previously enrolled in the RS1/001/10 study and received a subretinal injection of RetinoStat®. It's designed to follow up on those individuals to assess long-term safety related to their treatment for age-related macular degeneration.
What is being tested?
The focus of this study is on the long-term safety profile of RetinoStat®, an experimental gene therapy aimed at treating neovascular age-related macular degeneration, which was administered in a prior clinical trial.
What are the potential side effects?
Since this is a follow-up study, it will monitor for any delayed side effects from the initial RetinoStat® treatment. Specific side effects are not listed but may pertain to eye health and vision changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received a RetinoStat injection in my eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The incidence of adverse events
Secondary study objectives
The change from baseline in BCVA.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Long Term Follow upExperimental Treatment1 Intervention
Long Term follow up of patients who received RetinoStat in a previous study.

Find a Location

Who is running the clinical trial?

Oxford BioMedicaLead Sponsor
12 Previous Clinical Trials
1,039 Total Patients Enrolled
Peter Campochiaro, MDPrincipal InvestigatorJohn Hopkins University Hospital
5 Previous Clinical Trials
235 Total Patients Enrolled

Media Library

RetinoStat (Gene Transfer Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01678872 — Phase 1
Age-Related Macular Degeneration Research Study Groups: Long Term Follow up
Age-Related Macular Degeneration Clinical Trial 2023: RetinoStat Highlights & Side Effects. Trial Name: NCT01678872 — Phase 1
RetinoStat (Gene Transfer Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01678872 — Phase 1
~5 spots leftby Mar 2029
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