Clinical trial NCT06796673: Retina BioBank: Retina Biomarkers for a Deeper Understanding of Vitreoretinal and Systemic Diseases
Official title: Retina BioBank: Retina Biomarkers for a Deeper Understanding of Vitreoretinal and Systemic Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Other Retinal Disorders
Retinal Disease
Retinal Vascular Disorder
Lead sponsor: Greater Houston Retina Research
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retina Consultants of Texas patient population.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To quantify levels of disease state biomarkers implicated in the pathogenesis of various retinal and systemic pathologies
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
affiliation: Greater Houston Retina Research
name: Charles C. Wykoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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