Retinitis PigmentosaBIRPNCT01949623
Biomarkers In Retinitis Pigmentosa (BIRP)
An observational study of Retinitis Pigmentosa, 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 and plasma of RP patients compared to controls. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Anterior Chamber (AC) tap
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2017
- 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: Retinitis Pigmentosa patients and Controls
Who may be able to join
- Signed informed consent and authorization of use and disclosure of protected health information
- Age more than or equal to 18 years
- For the study group, patients diagnosed with Retinitis Pigmentosa by the investigators
- For the control group, patients undergoing vitreoretinal surgery for macular hole, epiretinal membrane, vitreomacular traction, retinal detachment, neovascular Age-related Macular Degeneration (AMD) and Diabetic Retinopathy will be eligible
Who cannot join
- Patients with active or suspected ocular or periocular infection
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 and plasma of RP patients compared to controls.
Read the detailed description
People with Retinitis Pigmentosa have loss of night vision followed by loss of central vision due to damage and death of photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers which can be measured. In this study, these biomarkers will be assessed in people with Retinitis Pigmentosa and compared to controls.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Anterior Chamber (AC) tap
- Keywords
- RP
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Chamber (AC) tapOther
Aqueous Samples will be collected for measurement of biomarkers
| Study group | Role | What they receive |
|---|---|---|
| RP patients | Retinitis Pigmentosa patients Receives: Other: Anterior Chamber (AC) tap | |
| Controls | Patients who will be undergoing surgery for macular hole, epiretinal membrane, or vitreomacular traction, patients who have a retinal detachment , patients with neovascular age related macular degeneration and patients with diabetic retinopathy. 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 markers of oxidative stress in patients with RP and controls.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Campochiaro, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949623
- Sponsor's protocol ID
- BIRP
- Acronym
- BIRP
- Status last verified
- Aug 2017
- First submitted
- 20 Sep 2013
- Last updated
- 16 Aug 2017
- 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 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers In Retinitis Pigmentosa (BIRP)
- ClinicalTrials.gov ID
- NCT01949623
- Acronym / sponsor ID
- BIRP / BIRP
- Conditions
- Retinitis Pigmentosa
- Keywords
- RP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Sep 2013 (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 and plasma of RP patients compared to controls.
Detailed description
People with Retinitis Pigmentosa have loss of night vision followed by loss of central vision due to damage and death of photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers which can be measured. In this study, these biomarkers will be assessed in people with Retinitis Pigmentosa and compared to controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RP patients | – | Other: Anterior Chamber (AC) tapRetinitis Pigmentosa patients |
| Controls | – | Other: Anterior Chamber (AC) tapPatients who will be undergoing surgery for macular hole, epiretinal membrane, or vitreomacular traction, patients who have a retinal detachment , patients with neovascular age related macular degeneration and patients with diabetic retinopathy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retinitis Pigmentosa patients and Controls
Key inclusion criteria (4 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- Age more than or equal to 18 years
- For the study group, patients diagnosed with Retinitis Pigmentosa by the investigators
- For the control group, patients undergoing vitreoretinal surgery for macular hole, epiretinal membrane, vitreomacular traction, retinal detachment, neovascular Age-related Macular Degeneration (AMD) and Diabetic Retinopathy will be eligible
Key exclusion criteria (1 listed)
- Patients with active or suspected ocular or periocular infection
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) tapAqueous Samples will be collected for measurement of biomarkers | Other | Controls, RP patients |
Primary outcome
Aqueous levels of markers of oxidative stress in patients with RP and controls.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- 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 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 Retinitis Pigmentosa, 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: finished, as of the sponsor's last update on 16 Aug 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 markers of oxidative stress in patients with RP and controls. (time frame: 2 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 16 Aug 2017.