RetinoStat® Safety for Age-Related Macular Degeneration

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oxford BioMedica

Disqualifiers: Did not receive RetinoStat, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Peter Campochiaro, MD

Principal Investigator

John Hopkins University Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have received a RetinoStat injection in my eye.

Must have been enrolled in Protocol RS1/001/10

Exclusion Criteria

Did not receive RetinoStat as part of the RS1/001/10 protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants received RetinoStat® in a previous study

Long Term Follow-up

Participants are monitored for long-term safety and changes in visual acuity

14 years

What Are the Treatments Tested in This Trial?

Interventions

• RetinoStat

Trial Overview 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.

How Is the Trial Designed?

Group I: Long Term Follow up Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Oxford BioMedica

Lead Sponsor

Trials

13

Recruited

1,100+