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

NCT06796673 | Enrolling By Invitation

• 1 other identifier: RBBK
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Other Retinal Disorders; Retinal Disease; Retinal Vascular Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

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

Study Population

Retina Consultants of Texas patient population.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Greater Houston Retina Research: lead

Study Sites (3)

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Related Publications (15)

• 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.

  PMID: 7526212 BACKGROUND

• Mesquida M, Drawnel F, Fauser S. The role of inflammation in diabetic eye disease. Semin Immunopathol. 2019 Jul;41(4):427-445. doi: 10.1007/s00281-019-00750-7. Epub 2019 Jun 7.

  PMID: 31175392 BACKGROUND

• Mesquita J, Castro-de-Sousa JP, Vaz-Pereira S, Neves A, Passarinha LA, Tomaz CT. Evaluation of the growth factors VEGF-a and VEGF-B in the vitreous and serum of patients with macular and retinal vascular diseases. Growth Factors. 2018 Apr;36(1-2):48-57. doi: 10.1080/08977194.2018.1477140. Epub 2018 Jul 3.

  PMID: 29969324 BACKGROUND

• Amadio M, Govoni S, Pascale A. Targeting VEGF in eye neovascularization: What's new?: A comprehensive review on current therapies and oligonucleotide-based interventions under development. Pharmacol Res. 2016 Jan;103:253-69. doi: 10.1016/j.phrs.2015.11.027. Epub 2015 Dec 8.

  PMID: 26678602 BACKGROUND

• Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003 Jan;22(1):1-29. doi: 10.1016/s1350-9462(02)00043-5.

  PMID: 12597922 BACKGROUND

• Zhang X, Bao S, Lai D, Rapkins RW, Gillies MC. Intravitreal triamcinolone acetonide inhibits breakdown of the blood-retinal barrier through differential regulation of VEGF-A and its receptors in early diabetic rat retinas. Diabetes. 2008 Apr;57(4):1026-33. doi: 10.2337/db07-0982. Epub 2008 Jan 3.

  PMID: 18174522 BACKGROUND

• Hofman P, Blaauwgeers HG, Tolentino MJ, Adamis AP, Nunes Cardozo BJ, Vrensen GF, Schlingemann RO. VEGF-A induced hyperpermeability of blood-retinal barrier endothelium in vivo is predominantly associated with pinocytotic vesicular transport and not with formation of fenestrations. Vascular endothelial growth factor-A. Curr Eye Res. 2000 Aug;21(2):637-45.

  PMID: 11148600 BACKGROUND

• Wu H, Hwang DK, Song X, Tao Y. Association between Aqueous Cytokines and Diabetic Retinopathy Stage. J Ophthalmol. 2017;2017:9402198. doi: 10.1155/2017/9402198. Epub 2017 Jun 7.

  PMID: 28680705 BACKGROUND

• Dong N, Xu B, Wang B, Chu L. Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis. 2013 Aug 4;19:1734-46. Print 2013.

  PMID: 23922491 BACKGROUND

• Kersten E, Paun CC, Schellevis RL, Hoyng CB, Delcourt C, Lengyel I, Peto T, Ueffing M, Klaver CCW, Dammeier S, den Hollander AI, de Jong EK. Systemic and ocular fluid compounds as potential biomarkers in age-related macular degeneration. Surv Ophthalmol. 2018 Jan-Feb;63(1):9-39. doi: 10.1016/j.survophthal.2017.05.003. Epub 2017 May 15.

  PMID: 28522341 BACKGROUND

• Knickelbein JE, Chan CC, Sen HN, Ferris FL, Nussenblatt RB. Inflammatory Mechanisms of Age-related Macular Degeneration. Int Ophthalmol Clin. 2015 Summer;55(3):63-78. doi: 10.1097/IIO.0000000000000073. No abstract available.

  PMID: 26035762 BACKGROUND

• Jonas JB, Tao Y, Neumaier M, Findeisen P. Cytokine concentration in aqueous humour of eyes with exudative age-related macular degeneration. Acta Ophthalmol. 2012 Aug;90(5):e381-8. doi: 10.1111/j.1755-3768.2012.02414.x. Epub 2012 Apr 10.

  PMID: 22490043 BACKGROUND

• Park KS, Kim JW, An JH, Woo JM. Elevated plasma pentraxin 3 and its association with retinal vein occlusion. Korean J Ophthalmol. 2014 Dec;28(6):460-5. doi: 10.3341/kjo.2014.28.6.460. Epub 2014 Nov 19.

  PMID: 25435748 BACKGROUND

• Noma H, Funatsu H, Yamasaki M, Tsukamoto H, Mimura T, Sone T, Hirayama T, Tamura H, Yamashita H, Minamoto A, Mishima HK. Aqueous humour levels of cytokines are correlated to vitreous levels and severity of macular oedema in branch retinal vein occlusion. Eye (Lond). 2008 Jan;22(1):42-8. doi: 10.1038/sj.eye.6702498. Epub 2006 Jul 7.

  PMID: 16826241 BACKGROUND

• Lopez-Contreras AK, Martinez-Ruiz MG, Olvera-Montano C, Robles-Rivera RR, Arevalo-Simental DE, Castellanos-Gonzalez JA, Hernandez-Chavez A, Huerta-Olvera SG, Cardona-Munoz EG, Rodriguez-Carrizalez AD. Importance of the Use of Oxidative Stress Biomarkers and Inflammatory Profile in Aqueous and Vitreous Humor in Diabetic Retinopathy. Antioxidants (Basel). 2020 Sep 20;9(9):891. doi: 10.3390/antiox9090891.

  PMID: 32962301 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor, vitreous humor, intraoperative tissue, and/or saliva will be collected.

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Charles C. Wykoff, MD, PhD

  Greater Houston Retina Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: January 28, 2025
• Study Start: April 11, 2022
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): August 1, 2032
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)