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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 15 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of adverse events
Secondary outcome measures
The change from baseline in BCVA.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available positions for participants in this clinical trial?

"At this time, the research study listed on clinicaltrials.gov is not in search of potential candidates. This trial was initially published August 1st 2012 and modified November 7th 2022 but it does not seem to be currently enrolling patients at present; however, there are other 159 trials actively recruiting people now."

Answered by AI

What safety protocols are in place for this therapeutic intervention?

"The safety of this intervention is rated 1 on our scale due to it being in Phase 1, leaving limited evidence for its efficacy and safety."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
What site did they apply to?
University of Iowa Hospitals & Clinics
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
2012. "A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01678872.
All > Age Related Macular Degeneration > Macular Degeneration
~5 spots leftby Mar 2029
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