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Clinical Trials in Italy / NCT07500324
Recruiting Not applicable

Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment

NCT07500324 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione G.B. Bietti, IRCCS
Phase
Not applicable
Started
2024-01-24
Last updated
2026-06-02

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Biological Sample Collection

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.

Study summary

This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration, 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Ability to understand the study procedures and provide written informed consent * Willingness and ability to comply with study procedures and visits For case subjects: * Patients with age-related macular degeneration (intermediate or advanced, including geographic atrophy or neovascular AMD) * Patients with diabetic retinopathy (non-proliferative or proliferative, with or without diabetic macular edema) * Patients undergoing surgery for primary or recurrent retinal detachment For control subjects: * Patients scheduled for cataract surgery with no documented retinal diseases (e.g., AMD, diabetic retinopathy, retinal vascular occlusions, or retinal epithelial disorders) * Outpatients with no documented retinal diseases * For retinal detachment subgroup: patients undergoing macular surgery (e.g., macular pucker or macular hole) or cataract surgery with attached retina Exclusion Criteria: * Age \< 18 years * Presence of infectious ocular diseases * Alterations in the electrophoretic profile of gamma globulins

Primary outcome measure(s)

  • Identification and Validation of Proteomic Biomarkers — Up to 36 months
    Identification and validation of protein biomarkers associated with age-related macular degeneration, diabetic retinopathy, and retinal detachment through clinical proteomics analysis of biological samples (ocular fluids and blood-derived components).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Fondazione G.B.Bietti Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07500324 on ClinicalTrials.gov ↗ ← All trials in Italy