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OpenTrials
Enrolling by Invitation

NCT Number: NCT06796673

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Consultants of Texas, Bellaire, Texas, United States

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About this study

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:

  • Men or women > 18 years of age
  • Subjects with vitreoretinal disease in at least one eye receiving a retinal treatment intervention
  • 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:

  • Screening for eligibility;
  • Aqueous humor collection (if applicable);
  • Vitreous humor collection (if applicable);
  • Intraoperative tissue (if applicable); and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Greater Houston Retina Research

Other

Registry information

Acronym: RBBK

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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