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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02875704
First received: August 18, 2016
Last updated: September 2, 2016
Last verified: September 2016
  Purpose
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 Intervention
Stargardt Disease
Diabetic Retinopathy
Macular Degeneration (Age Related)
Other: Anterior Chamber Tap

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 160
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stargardt disease, AMD, DR patients
Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients
Other: Anterior Chamber 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 Tap
Aqueous Samples will be collected for measurement of biomarkers
Other Name: 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.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02875704

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

Locations
United States, Maryland
Wilmer Eye Institute Not yet 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
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
  More Information

Responsible Party: Peter A Campochiaro, MD, Professor of Ophthalmology and Neuroscience, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02875704     History of Changes
Other Study ID Numbers: OXI-SAD 
Study First Received: August 18, 2016
Last Updated: September 2, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
DR
AMD

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
Macular Degeneration
Diabetic Retinopathy
Retinal Degeneration
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus

ClinicalTrials.gov processed this record on December 09, 2016