Age-Related Macular DegenerationPhase 1NCT01678872
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
A Phase 1 study testing RetinoStat in people with Age-Related Macular Degeneration, run by Oxford BioMedica at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- RetinoStat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have received a subretinal injection of RetinoStat
- Must have been enrolled in Protocol RS1/001/10
Who cannot join
- Did not receive RetinoStat® as part of the RS1/001/10 protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Hopkins University Hospital
Baltimore, Maryland, 21287-9277
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52245
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- RetinoStat
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetinoStatDrug
Long Term Follow up of patients who received RetinoStat in a previous study
| Study group | Role | What they receive |
|---|---|---|
| Long Term Follow up | Other | Long Term follow up of patients who received RetinoStat in a previous study. Receives: Drug: RetinoStat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
The number of subjects with treatment emergent adverse events.
Measured: 14 years
Secondary outcomes (1)
The change from baseline in BCVA.
The change from baseline in Best Corrective Visual Acuity.
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford BioMedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Campochiaro, MD, Principal investigator, John Hopkins University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678872
- Sponsor's protocol ID
- RS1/002/11
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2012
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01678872
- Acronym / sponsor ID
- RS1/002/11
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Oxford BioMedicaIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long Term Follow up | Other | Drug: RetinoStatLong Term follow up of patients who received RetinoStat in a previous study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have received a subretinal injection of RetinoStat
- Must have been enrolled in Protocol RS1/001/10
Key exclusion criteria (1 listed)
- Did not receive RetinoStat® as part of the RS1/001/10 protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetinoStatLong Term Follow up of patients who received RetinoStat in a previous study | Drug | Long Term Follow up |
Primary outcome
The incidence of adverse events
Time frame: 14 years
The number of subjects with treatment emergent adverse events.
1 secondary outcome
The change from baseline in BCVA.
Time frame: 14 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Campochiaro, MD principal investigator
John Hopkins University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RetinoStat in people with Age-Related Macular Degeneration, run by Oxford BioMedica at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (time frame: 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.