Retina BioBank: Retina Biomarkers for a Deeper Understand... | NCT06796673

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

NCT06796673

Sponsor

Greater Houston Retina Research

Status

Enrolling by invitation

Last Update Posted

Jan 28, 2025Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Other Retinal Disorders
Retinal Disease
Retinal Vascular Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2022Actual

Primary Completion Date

Apr 2032Estimated

Completion Date

Aug 2032Estimated

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Jan 22, 2025

First Posted Date

Jan 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2025

Last Update Posted Date

Jan 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To quantify levels of disease state biomarkers implicated in the pathogenesis of various retinal and systemic pathologies	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Retina Consultants of Texas patient population.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles C. Wykoff, MD, PhD	Greater Houston Retina Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Consultants of Texas		Bellaire	Texas	77401	United States
Retina Consultants of Texas

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7526212	Background	Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.
31175392	Background