A Follow-up Study to Evaluate the Safety of RetinoStat® i... | NCT01678872

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

NCT01678872

Sponsor

Oxford BioMedica

Status

Active, not recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

18Estimated

Phase

Phase 1

Conditions

Age-Related Macular Degeneration

Interventions

RetinoStat

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Mar 2029Estimated

Completion Date

Mar 2029Estimated

First Submitted Date

Aug 31, 2012

First Submission Date that Met QC Criteria

Sep 4, 2012

First Posted Date

Sep 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Long Term Follow up	Other	Long Term follow up of patients who received RetinoStat in a previous study.	Drug: RetinoStat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RetinoStat	Drug	Long Term Follow up of patients who received RetinoStat in a previous study	Long Term Follow up

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Campochiaro, MD	John Hopkins University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Hospitals & Clinics		Iowa City	Iowa	52245	United States
John Hopkins University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided