Age-Related Macular Degeneration (AMD)PRO ProjectNCT07500324
Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment
A study testing Biological Sample Collection in people with Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), Retinal Detachment
- What is being tested?
- Biological Sample Collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- Age < 18 years
- Presence of infectious ocular diseases
- Alterations in the electrophoretic profile of gamma globulins
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tommaso Rossi, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione G.B.Bietti
Roma, Italy, 00184
Mariacristina Parravano, MD, +390684009442, mariacristina.parravano@fondazionebietti.it
About this study
Official title: Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
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.
Read the detailed description
This is a single-center, prospective interventional translational study designed to identify and validate proteomic biomarkers in patients affected by age-related macular degeneration, diabetic retinopathy, and retinal detachment, compared with control subjects without retinal disease.
Study Population
Approximately 260 subjects will be enrolled, including:
180 patients (100 age-related macular degeneration, 50 diabetic retinopathy, 30 retinal detachment) 80 controls (cataract surgery or macular surgery patients without retinal disease). Participants will be recruited among patients routinely treated at IRCCS Fondazione G.B. Bietti.
Study Design and Procedures
All participants will undergo a baseline visit including:
- Medical and ophthalmological history comprehensive eye examination (visual acuity, tonometry, biomicroscopy, ophthalmoscopy)
- Non-invasive imaging (e.g., Optical Coherence Tomography, Optical Coherence Tomography Angiography)
- Collection of tears and peripheral blood samples
Patients undergoing therapeutic procedures will also participate in a second visit (within 1-30 days), during which additional biological samples will be collected during routine clinical care, including:
- Aqueous humor (via paracentesis)
- Vitreous humor
- Subretinal fluid (in retinal detachment surgery) Post-injection vitreous reflux (if applicable) All sampling procedures are performed as part of standard clinical or surgical practice and do not introduce additional risk to the patient.
Proteomic Analysis Collected biological matrices (ocular fluids and blood-derived components such as PBMCs and extracellular vesicles) will be analyzed using advanced clinical proteomics techniques. These include high-resolution mass spectrometry (Orbitrap-based platforms) combined with multiplex quantitative approaches (e.g., Tandem Mass Tags).
The study will follow a two-phase approach:
Biomarker discovery phase, aimed at identifying candidate protein biomarkers Validation phase, aimed at confirming their diagnostic and biological relevance Additional targeted analyses (e.g., ELISA) and functional studies (e.g., in vitro cellular models) may be performed to further characterize identified molecular pathways.
Objectives The primary objective is the identification and validation of protein biomarkers associated with age-related macular degeneration, diabetic retinopathy, and retinal detachment.
Secondary objectives include:
Characterization of molecular mechanisms underlying disease pathogenesis Identification of potential therapeutic targets Investigation of post-translational protein modifications (e.g., phosphoproteomics, ubiquitin-related signatures) Evaluation of surgical variables (e.g., vitreous fragmentation) in biomarker identification
Statistical Analysis Data will be analyzed using appropriate parametric and non-parametric statistical methods. Associations between clinical and molecular variables will be explored, with statistical significance defined as p < 0.05.
Ethical and Data Management Considerations The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants will provide written informed consent prior to enrollment. Data will be pseudonymized and handled in compliance with applicable data protection regulations (General Data Protection Regulatio)
- Being tested
- Biological Sample Collection
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Sample CollectionDevice
Also called Collection of Ocular Fluids and Blood Samples, Ocular and Blood 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 group | Role | What they receive |
|---|---|---|
| Ophthalmic Patients Undergoing Clinical Proteomic Sampling | Other | Biological sample collection during routine clinical care for proteomic biomarker analysis Receives: Device: Biological Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start24 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500324
- Sponsor's protocol ID
- RET 03-23
- Acronym
- PRO Project
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
- ClinicalTrials.gov ID
- NCT07500324
- Acronym / sponsor ID
- PRO Project / RET 03-23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective interventional translational study designed to identify and validate proteomic biomarkers in patients affected by age-related macular degeneration, diabetic retinopathy, and retinal detachment, compared with control subjects without retinal disease.
Study Population
Approximately 260 subjects will be enrolled, including:
180 patients (100 age-related macular degeneration, 50 diabetic retinopathy, 30 retinal detachment) 80 controls (cataract surgery or macular surgery patients without retinal disease). Participants will be recruited among patients routinely treated at IRCCS Fondazione G.B. Bietti.
Study Design and Procedures
All participants will undergo a baseline visit including:
- Medical and ophthalmological history comprehensive eye examination (visual acuity, tonometry, biomicroscopy, ophthalmoscopy)
- Non-invasive imaging (e.g., Optical Coherence Tomography, Optical Coherence Tomography Angiography)
- Collection of tears and peripheral blood samples
Patients undergoing therapeutic procedures will also participate in a second visit (within 1-30 days), during which additional biological samples will be collected during routine clinical care, including:
- Aqueous humor (via paracentesis)
- Vitreous humor
- Subretinal fluid (in retinal detachment surgery) Post-injection vitreous reflux (if applicable) All sampling procedures are performed as part of standard clinical or surgical practice and do not introduce additional risk to the patient.
Proteomic Analysis Collected biological matrices (ocular fluids and blood-derived components such as PBMCs and extracellular vesicles) will be analyzed using advanced clinical proteomics techniques. These include high-resolution mass spectrometry (Orbitrap-based platforms) combined with multiplex quantitative approaches (e.g., Tandem Mass Tags).
The study will follow a two-phase approach:
Biomarker discovery phase, aimed at identifying candidate protein biomarkers Validation phase, aimed at confirming their diagnostic and biological relevance Additional targeted analyses (e.g., ELISA) and functional studies (e.g., in vitro cellular models) may be performed to further characterize identified molecular pathways.
Objectives The primary objective is the identification and validation of protein biomarkers associated with age-related macular degeneration, diabetic retinopathy, and retinal detachment.
Secondary objectives include:
Characterization of molecular mechanisms underlying disease pathogenesis Identification of potential therapeutic targets Investigation of post-translational protein modifications (e.g., phosphoproteomics, ubiquitin-related signatures) Evaluation of surgical variables (e.g., vitreous fragmentation) in biomarker identification
Statistical Analysis Data will be analyzed using appropriate parametric and non-parametric statistical methods. Associations between clinical and molecular variables will be explored, with statistical significance defined as p < 0.05.
Ethical and Data Management Considerations The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants will provide written informed consent prior to enrollment. Data will be pseudonymized and handled in compliance with applicable data protection regulations (General Data Protection Regulatio)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmic Patients Undergoing Clinical Proteomic Sampling | Other | Device: Biological Sample CollectionBiological sample collection during routine clinical care for proteomic biomarker analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Ability to understand the study procedures and provide written informed consent
- Willingness and ability to comply with study procedures and visits
- 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)
Key exclusion criteria (3 listed)
- Age < 18 years
- Presence of infectious ocular diseases
- Alterations in the electrophoretic profile of gamma globulins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological Sample CollectionAlso: Collection of Ocular Fluids and Blood Samples, Ocular and Blood Sample CollectionBiological 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. | Device | Ophthalmic Patients Undergoing Clinical Proteomic Sampling |
Primary outcome
Identification and Validation of Proteomic Biomarkers
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tommaso Rossi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Sample Collection in people with Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariacristina Parravano, MD (+390684009442, mariacristina.parravano@fondazionebietti.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and Validation of Proteomic Biomarkers (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.