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

September 22, 2022 updated by: Johns Hopkins University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

77

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

Stargardt disease, AMD, DR patients and controls

Description

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

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

Sponsor

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)

January 3, 2017

Primary Completion (Actual)

June 6, 2022

Study Completion (Actual)

September 22, 2022

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00112564
  • OXI-SAD (Other Identifier: Other)

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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