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Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT02875704
Collaborator
(none)
77
Enrollment
1
Location
65.1
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Anterior Chamber (AC) Tap

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

Study Type:
Observational
Actual Enrollment :
77 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy
Actual Study Start Date :
Jan 3, 2017
Actual Primary Completion Date :
Jun 6, 2022
Actual Study Completion Date :
Jun 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Stargardt disease, AMD, DR patients

Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients

Other: Anterior Chamber (AC) Tap
Aqueous Samples will be collected for measurement of biomarkers
Other Names:
  • AC Tap

    		•
    Controls

    Patients without retinal disease who will be undergoing cataract surgery

    Other: Anterior Chamber (AC) Tap
    Aqueous Samples will be collected for measurement of biomarkers
    Other Names:
  • AC Tap

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wilmer Eye Institute Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT02875704
    Other Study ID Numbers:
    • IRB00112564
    • OXI-SAD
    First Posted:
    Aug 23, 2016
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Johns Hopkins University
    DR
    AMD
    Additional relevant MeSH terms:
    Macular Degeneration
    Retinal Diseases
    Diabetic Retinopathy
    Stargardt Disease

    Study Results

    No Results Posted as of Jun 30, 2022