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

NCT ID: NCT01678872

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2029-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age-Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Long Term Follow up

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

Group Type OTHER

RetinoStat

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RetinoStat

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oxford BioMedica

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Campochiaro, MD

Role: PRINCIPAL_INVESTIGATOR

John Hopkins University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

John Hopkins University Hospital

Baltimore, Maryland, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RS1/002/11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy
NCT03999801 ENROLLING_BY_INVITATION PHASE2