NCT01678872

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
34mo left

Started Aug 2012

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2012Mar 2029

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

16.6 years

First QC Date

August 31, 2012

Last Update Submit

January 12, 2026

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events

    The number of subjects with treatment emergent adverse events.

    14 years

Secondary Outcomes (1)

  • The change from baseline in BCVA.

    14 years

Study Arms (1)

Long Term Follow up

OTHER

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

Drug: RetinoStat

Interventions

RetinoStatDRUG

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

Long Term Follow up

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have received a subretinal injection of RetinoStat
  • Must have been enrolled in Protocol RS1/001/10

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52245, United States

Location

John Hopkins University Hospital

Baltimore, Maryland, 21287-9277, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Peter Campochiaro, MD

    John Hopkins University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

August 1, 2012

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

US(3)