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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2029

Interventions

  • Drug: RetinoStat
    • Long Term Follow up of patients who received RetinoStat in a previous study

Arms, Groups and Cohorts

  • Other: Long Term Follow up
    • Long Term follow up of patients who received RetinoStat in a previous study.

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of adverse events
    • Time Frame: 15 years
    • The number of subjects with treatment emergent adverse events.

Secondary Measures

  • The change from baseline in BCVA.
    • Time Frame: 15 years
    • The change from baseline in Best Corrective Visual Acuity.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oxford BioMedica
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Campochiaro, MD, Principal Investigator, John Hopkins University Hospital

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