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

Terminated

• Conditions: Macular Degeneration (Age Related); Stargardt Disease; Diabetic Retinopathy
• Interventions: Other: Anterior Chamber (AC) Tap

• Registration Number: NCT02875704
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Study Start: 2017-01-03
• Status Verified: 2022-06
• Primary Completion: 2022-06-06
• Study Completion: 2022-09-22
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stargardt disease, AMD, DR patients	Anterior Chamber (AC) Tap	Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients
Controls	Anterior Chamber (AC) Tap	Patients without retinal disease who will be undergoing cataract surgery

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States