Biomarkers In Retinitis Pigmentosa (BIRP) (BIRP)

August 14, 2017 updated by: Johns Hopkins University
In this study, markers of oxidative stress will be measured in the aqueous humour and plasma of RP patients compared to controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retinitis Pigmentosa patients and Controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aqueous levels of markers of oxidative stress in patients with RP and controls.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Peter Campochiaro, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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