Retina BioBank: Retina Biomarkers for a Deeper Understanding of Vitreoretinal and Systemic Diseases (RBBK)

January 22, 2025 updated by: Greater Houston Retina Research
The RBBK study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The RBBK study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies.

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Men or women > 18 years of age
  2. Subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention
  3. Able and willing to provide signed informed consent

The study will consist of a single visit and a retrospective chart review. The study visit will consist of:

  1. Screening for eligibility;
  2. Aqueous humor collection (if applicable);
  3. Vitreous humor collection (if applicable);
  4. Intraoperative tissue (if applicable); and
  5. Saliva collection

If applicable, approximately 50 microliters (or more, up to 1000 microliters) of aqueous fluid will be collected by anterior chamber paracentesis according to standard clinical procedures. If applicable, up to 2 milliliters of vitreous fluid will be collected according to standard clinical procedures. Specific tissue, such as scar tissue, are routinely removed from the eye during vitreoretinal procedures. When being removed during a standard of care surgical procedure, these tissues may be collected. Saliva will also be collected according to instructions found in the Saliva Oragene Dx Collection Kit.

Study Type

Observational

Enrollment (Estimated)

10000

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
    • Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retina Consultants of Texas patient population.

Description

Inclusion Criteria:

1. Subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention

Exclusion Criteria:

  1. Prior intraocular or subtenon steroid injection in the study eye within the prior 1 month of signing informed consent
  2. Intraocular or refractive surgery in the study eye within 30 days of signing informed consent
  3. Systemic anti-VEGF treatment within 90 days of signing informed consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To quantify levels of disease state biomarkers implicated in the pathogenesis of various retinal and systemic pathologies
Time Frame: Baseline
An analysis of the ocular fluids and tissues of patients with various vitreoretinal diseases would allow for the development of a deeper understanding of the processes that contribute to their onset and may ultimately provide insight in methods to refine treatment and management options.
Baseline

Collaborators and Investigators

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

Sponsor

Greater Houston Retina Research

Investigators

  • Principal Investigator: Charles C. Wykoff, MD, PhD, Greater Houston Retina Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 11, 2022

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBBK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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