NCT01949623

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

September 20, 2013

Last Update Submit

August 14, 2017

Conditions

Keywords

RP

Outcome Measures

Primary Outcomes (1)

  • Aqueous levels of markers of oxidative stress in patients with RP and controls.

    2 years

Study Arms (2)

RP patients

Retinitis Pigmentosa patients

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.

Other: Anterior Chamber (AC) tap

Interventions

Aqueous Samples will be collected for measurement of biomarkers

ControlsRP patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retinitis Pigmentosa patients and Controls

You may qualify if:

  • 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

You may not qualify if:

  • Patients with active or suspected ocular or periocular infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anterior Chamber fluid from the eye

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDrainageTherapeuticsPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Peter Campochiaro, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

September 24, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations