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Biomarkers In Retinitis Pigmentosa (BIRP) (BIRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01949623
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
In this study, markers of oxidative stress will be measured in the aqueous humour and plasma of RP patients compared to controls.

Condition or disease Intervention/treatment
Retinitis Pigmentosa Other: Anterior Chamber (AC) tap

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers In Retinitis Pigmentosa (BIRP)
Actual Study Start Date : September 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RP patients
Retinitis Pigmentosa patients
Other: Anterior Chamber (AC) tap
Aqueous Samples will be collected for measurement of biomarkers

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.
Other: Anterior Chamber (AC) tap
Aqueous Samples will be collected for measurement of biomarkers




Primary Outcome Measures :
  1. Aqueous levels of markers of oxidative stress in patients with RP and controls. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Anterior Chamber fluid from the eye


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retinitis Pigmentosa patients and Controls
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with active or suspected ocular or periocular infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949623


Locations
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United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Peter Campochiaro, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01949623    
Other Study ID Numbers: BIRP
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
RP
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn