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

NCT02875704 | Terminated

• 2 other identifiers: IRB00112564OXI-SAD
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Stargardt Disease; Diabetic Retinopathy; Macular Degeneration (Age Related)

Keywords

DR; AMD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stargardt disease, AMD, DR patients

Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients

Other: Anterior Chamber (AC) Tap

Controls

Patients without retinal disease who will be undergoing cataract surgery

Other: Anterior Chamber (AC) Tap

Interventions

Anterior Chamber (AC) Tap OTHER

Aqueous Samples will be collected for measurement of biomarkers

Also known as: AC Tap

Controls; Stargardt disease, AMD, DR patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stargardt disease, AMD, DR patients and controls

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will only be used for measurement of biomarkers of oxidative stress

MeSH Terms

Conditions

Stargardt Disease; Diabetic Retinopathy; Macular Degeneration

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Peter A Campochiaro, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: January 3, 2017
• Primary Completion: June 6, 2022
• Study Completion: September 22, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)