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

April 11, 2024 updated by: Oxford BioMedica

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52245
        • University of Iowa Hospitals & Clinics
    • Maryland
      • Baltimore, Maryland, United States, 21287-9277
        • John Hopkins University Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Long Term Follow up
Long Term follow up of patients who received RetinoStat in a previous study.
Drug: RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford BioMedica

Investigators

  • Principal Investigator: Peter Campochiaro, MD, John Hopkins University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimated)

September 5, 2012

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1/002/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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