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NCT00331331

The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease

Completed Last updated 30 October 2024
What this trial tests

trial in Uveitis in 147 participants. Completed in 1 February 2019.

Timeline
14 February 2007
Primary endpoint
1 February 2019
1 February 2019

Quick facts

Lead sponsorNational Eye Institute (NEI)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment147
Start date14 February 2007
Primary completion1 February 2019
Estimated completion1 February 2019
Sites1 location across United States

Conditions studied

Sponsor

National Eye Institute (NEI)

Who can join

18 and older, any sex, with Uveitis or Vasculitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening uveitis. Up to 300 participants, ages 18 and older with the appropriate ocular disorders and where vitreous or anterior chamber fluid specimens can be obtained, will be enrolled in the study. This number includes participants that were previously enrolled as part of the Multicenter Uveitis Steroid Treatment (MUST) study, as well as patients who participate in other intramural NIH studies and agree to participate in this study. Researchers will study the vitreous that will be removed from patients' eyes during an operation to insert a steroid implant. The steroid implant is used instead of immunosuppressive therapy, a way to reduce the action of the immune system. Patients will undergo a procedure involving a small hole made in the eye into which the implant is placed. Normally a small amount of the vitreous comes out during that procedure, and in this study, the vitreous specimen will be taken for testing of inflammatory products. At the same time, a small sample of blood, about 1-1/2 tablespoons, will be collected so that the researchers can compare inflammatory products that may be in the blood with those in the vitreous. If a patient needs to have the implant placed again during the study, he or she would be asked permission for collection of the vitreous and blood samples, as previously. Samples collected will not be used to diagnose patients' conditions or to change any treatments being done. All samples will be labeled with special code numbers so that there is no identifying information about patients. This study will not involve examinations or scheduled visits of patients.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
    Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
  2. Advances in Extracellular-Vesicles-Based Diagnostic and Therapeutic Approaches for Ocular Diseases.
    Su Y, Chen M, Xu W, Gu P, et al · · 2024 · cited 23× · PMID 39141830 · DOI 10.1021/acsnano.4c08486
  3. Role of stem cell derivatives in inflammatory diseases.
    Yang Y, Peng Y, Li Y, Shi T, et al · · 2023 · cited 13× · PMID 37006266 · DOI 10.3389/fimmu.2023.1153901
  4. Exosomes in Ocular Health: Recent Insights into Pathology, Diagnostic Applications and Therapeutic Functions.
    Blanco-Agudín N, Ye S, González-Fernández S, Alcalde I, et al · · 2025 · cited 9× · PMID 39857816 · DOI 10.3390/biomedicines13010233
  5. Basic Pathogenic Mechanisms and Epigenetic Players Promoted by Extracellular Vesicles in Vascular Damage.
    Schiano C, Balbi C, de Nigris F, Napoli C. · · 2023 · cited 7× · PMID 37108672 · DOI 10.3390/ijms24087509
  6. Exosomes: the future of acellular nanotherapeutics in regenerative vascularization.
    Dawes JS, Abdelaal M, Landmesser ME, Asgardoon MH, et al · · 2025 · cited 1× · PMID 40979643 · DOI 10.3389/fbioe.2025.1607605

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Data sources for this page

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