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

NCT ID: NCT02875704

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-03

Study Completion Date

2022-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stargardt Disease Diabetic Retinopathy Macular Degeneration (Age Related)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stargardt disease, AMD, DR patients

Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients

Anterior Chamber (AC) Tap

Intervention Type OTHER

Aqueous Samples will be collected for measurement of biomarkers

Controls

Patients without retinal disease who will be undergoing cataract surgery

Anterior Chamber (AC) Tap

Intervention Type OTHER

Aqueous Samples will be collected for measurement of biomarkers

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anterior Chamber (AC) Tap

Aqueous Samples will be collected for measurement of biomarkers

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AC Tap

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter A Campochiaro, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wilmer Eye Institute

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OXI-SAD

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00112564

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Saffron Supplementation in Stargardt's Disease
NCT01278277 UNKNOWN PHASE1/PHASE2
Effects of Lutein in Retinitis Pigmentosa
NCT00029289 COMPLETED PHASE1/PHASE2
"Night Vision and Carotenoids"
NCT04741763 COMPLETED NA