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NCT02875704 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02875704
Other study ID # IRB00112564
Secondary ID OXI-SAD
Status Terminated
Phase
First received
Last updated
Start date January 3, 2017
Est. completion date September 22, 2022

Study information
Verified date June 2022
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 77
Est. completion date September 22, 2022
Est. primary completion date June 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Wilmer Eye Institute Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls 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
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