Proteomic Biomarker Identification in AMD, Diabetic Retinopathy and Retinal Detachment

NCT07500324 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-03-30

No results posted yet for this study

Summary

This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration (AMD), diabetic retinopathy (DR), and retinal detachment (RD). A total of approximately 260 participants (cases and controls) will be enrolled at a single center.

Biological samples, including peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, will be collected during routine clinical and surgical procedures. Advanced clinical proteomics approaches will be applied to characterize molecular signatures associated with disease onset, progression, and response to treatment.

The study seeks to improve the understanding of disease pathophysiology and support the development of novel diagnostic and prognostic biomarkers in ophthalmology.

Conditions

  • Age-Related Macular Degeneration (AMD)
  • Diabetic Retinopathy (DR)
  • Retinal Detachment

Interventions

DEVICE

Biological Sample Collection

Biological samples will be collected from study participants during routine clinical evaluation and/or standard surgical procedures. Samples include peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, depending on the patient's clinical condition and scheduled treatment. Tear and blood samples will be obtained at baseline, while ocular fluids will be collected intraoperatively or during intravitreal procedures, without introducing additional risks or procedures beyond standard clinical care. All samples will be processed and analyzed using advanced clinical proteomics techniques, including high-resolution mass spectrometry, to identify and validate protein biomarkers associated with ophthalmological diseases.

Sponsors & Collaborators

  • Fondazione G.B. Bietti, IRCCS

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07500324 on ClinicalTrials.gov