NCT07500324 Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment
| NCT ID | NCT07500324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione G.B. Bietti, IRCCS |
| Condition | Age-Related Macular Degeneration (AMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2024-01-24 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07500324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Age-Related Macular Degeneration (AMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07500324 currently recruiting?
Yes, NCT07500324 is actively recruiting participants. Contact the research team at mariacristina.parravano@fondazionebietti.it for enrollment information.
Where is the NCT07500324 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07500324 clinical trial?
NCT07500324 is sponsored by Fondazione G.B. Bietti, IRCCS. The trial plans to enroll 260 participants.