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

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ClinicalTrials.gov Identifier: NCT02875704
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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
Stargardt Disease Diabetic Retinopathy Macular Degeneration (Age Related) 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
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Study Type : Observational
Estimated Enrollment : 160 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 : January 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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 Name: 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 Name: AC Tap


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


Biospecimen Retention:   Samples Without DNA
Samples will only be used for measurement of biomarkers of oxidative stress

Eligibility Criteria
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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
Stargardt disease, AMD, DR patients and controls
Criteria

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
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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): NCT02875704


Contacts
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Contact: Gulnar Hafiz, MD, MPH ghafiz1@jhmi.edu

Locations
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United States, Maryland
Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Gulnar Hafiz, MD, MPH       ghafiz1@jhmi.edu   
Principal Investigator: Peter Campochiaro, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02875704    
Other Study ID Numbers: IRB00112564
OXI-SAD ( Other Identifier: Other )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
DR
AMD
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Stargardt Disease
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn