Stargardt DiseaseNCT02875704
Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy
An observational study of Stargardt Disease and Diabetic Retinopathy, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stargardt Disease, Diabetic Retinopathy, Macular Degeneration (Age Related)
- What is being tested?
- Anterior Chamber (AC) Tap
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 22 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stargardt disease, AMD, DR patients and controls
Who may be able to join
- Signed informed consent and authorization of use and disclosure of protected health information
- Age at least 18 years
- For the study group, patients diagnosed with Stargardt disease, age related macular degeneration and diabetic retinopathy by the investigators, based on clinical phenotype
- For the control group, patients with no retinal disease undergoing cataract surgery will be eligible.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls.
Read the detailed description
People with Stargardt disease, age related macular degeneration (AMD) and diabetic retinopathy (DR) have decrease in central vision from damage to photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers that can be measured in eye fluid (aqueous humor). In this study, these biomarkers will be assessed in people with Stargardt disease, age related macular degeneration and diabetic retinopathy, compared to controls.
- Being tested
- Anterior Chamber (AC) Tap
- Keywords
- DR, AMD
- Medical subject headings
- Stargardt Disease, Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Chamber (AC) TapOther
Also called AC Tap
Aqueous Samples will be collected for measurement of biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Stargardt disease, AMD, DR patients | Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients Receives: Other: Anterior Chamber (AC) Tap | |
| Controls | Patients without retinal disease who will be undergoing cataract surgery Receives: Other: Anterior Chamber (AC) Tap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls
Baseline = Day of clinic visit for stargardt disease, AMD, DR patients and day of surgery for patients undergoing cataract surgery. No follow up is required.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start3 Jan 2017
- Primary completion6 Jun 2022
- Study completion22 Sep 2022
Why it stopped: There was no significant difference in our outcome measures between patients with disease versus controls suggesting that our hypothesis is not substantiated. Since this was the major objective of the study we decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stargardt DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter A Campochiaro, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875704
- Sponsor's protocol ID
- IRB00112564
- Other IDs
- OXI-SAD
- Status last verified
- Jun 2022
- First submitted
- 18 Aug 2016
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02875704
- Acronym / sponsor ID
- IRB00112564
- Keywords
- DR, AMD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: There was no significant difference in our outcome measures between patients with disease versus controls suggesting that our hypothesis is not substantiated. Since this was the major objective of the study we decided to terminate the study.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 23 Aug 2016 (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.
In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls.
Detailed description
People with Stargardt disease, age related macular degeneration (AMD) and diabetic retinopathy (DR) have decrease in central vision from damage to photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers that can be measured in eye fluid (aqueous humor). In this study, these biomarkers will be assessed in people with Stargardt disease, age related macular degeneration and diabetic retinopathy, compared to controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stargardt disease, AMD, DR patients | – | Other: Anterior Chamber (AC) TapStargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients |
| Controls | – | Other: Anterior Chamber (AC) TapPatients without retinal disease who will be undergoing cataract surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stargardt disease, AMD, DR patients and controls
Key inclusion criteria (4 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- Age at least 18 years
- For the study group, patients diagnosed with Stargardt disease, age related macular degeneration and diabetic retinopathy by the investigators, based on clinical phenotype
- For the control group, patients with no retinal disease undergoing cataract surgery will be eligible.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Anterior Chamber (AC) TapAlso: AC TapAqueous Samples will be collected for measurement of biomarkers | Other | Controls, Stargardt disease, AMD, DR patients |
Primary outcome
Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls
Time frame: Baseline
Baseline = Day of clinic visit for stargardt disease, AMD, DR patients and day of surgery for patients undergoing cataract surgery. No follow up is required.
Results and safety
The study was stopped early (reason given: There was no significant difference in our outcome measures between patients with disease versus controls suggesting that our hypothesis is not substantiated. Since this was the major objective of the study we decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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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 A Campochiaro, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stargardt Disease and Diabetic Retinopathy, run by Johns Hopkins University at 1 site 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 4 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: stopped early, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: There was no significant difference in our outcome measures between patients with disease versus controls suggesting that our hypothesis is not substantiated. Since this was the major objective of the study we decided to terminate the study.). Results are not available in the source record.
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?
Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls (time frame: Baseline). 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 26 Sep 2022.