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

NCT07500324 | Recruiting

• 1 other identifier: RET 03-23
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Identification and Validation of Proteomic Biomarkers

  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).

  Up to 36 months

Study Arms (1)

Ophthalmic Patients Undergoing Clinical Proteomic Sampling

OTHER

Biological sample collection during routine clinical care for proteomic biomarker analysis

Device: Biological Sample Collection

Interventions

Biological Sample Collection DEVICE

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.

Also known as: Collection of Ocular Fluids and Blood Samples, Ocular and Blood Sample Collection

Ophthalmic Patients Undergoing Clinical Proteomic Sampling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Presence of infectious ocular diseases
• Alterations in the electrophoretic profile of gamma globulins

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

IRCCS Fondazione G.B.Bietti

Roma, Italy, 00184, Italy

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Retinal Detachment

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mariacristina Parravano, MD

CONTACT

+390684009442; mariacristina.parravano@fondazionebietti.it

Tommaso Rossi, MD

CONTACT

tommaso.rossi@fondazionebietti.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: January 24, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)