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Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Fondazione G.B.Bietti
RECRUITING
Roma
Contact Information
Primary
Mariacristina Parravano, MD
mariacristina.parravano@fondazionebietti.it
+390684009442
Backup
Tommaso Rossi, MD
tommaso.rossi@fondazionebietti.it
Time Frame
Start Date: 2024-01-24
Estimated Completion Date: 2027-01
Participants
Target number of participants: 260
Treatments
Other: Ophthalmic Patients Undergoing Clinical Proteomic Sampling
Biological sample collection during routine clinical care for proteomic biomarker analysis
Related Therapeutic Areas
Retinal Detachment
Diabetic Retinopathy
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Fondazione G.B. Bietti, IRCCS

This content was sourced from clinicaltrials.gov

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