Retinal DiseasesRET 05-26NCT07615699
Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases
An observational study of Retinal Diseases and Choroidal Diseases, run by Fondazione G.B. Bietti, IRCCS.
Trial summary
The purpose of this prospective, longitudinal, single-center observational study is to identify, describe, and measure the morpho-functional characteristics and modifications of the retina and choroid using advanced multimodal imaging techniques. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Diseases, Choroidal Diseases, Healthy Subjects
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 1 Jun 2033
- Phase
- Observational
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of both healthy volunteers and patients diagnosed with any type of retino-choroidal pathology. Participants will be selected from individuals who routinely attend or are referred to the outpatient clinics at the IRCCS Fondazione G. B. Bietti in Rome, Italy. The sample is designed to include a wide age range (age ≥ 6 years old) to capture the natural progression and morpho-functional characteristics of these conditions across different demographics. The cohort will feature a 4:1 allocation ratio, comprising 100 patients with retino-choroidal diseases and 25 age- and sex-matched healthy controls to ensure adequate statistical power for longitudinal progression analysis.
Who may be able to join
- freely given informed consent acquired prior to the start of the study.
- Participant's capacity to understand the informed consent and study procedures.
- Age ≥ 6 years (with parental/guardian consent for minors).
- Patients affected by any retino-choroidal disease.
- Healthy subjects showing no retino-choroidal pathology.
Who cannot join
- Patient unable and/or unwilling to cooperate.
- Presence of media opacities (dioptric media) that prevent image acquisition or significantly reduce the quality of the obtained images.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Costanzo contact
About this study
Official title: Valutazione Morfo-funzionale Della Retina e Della Coroide Mediante Imaging Multimodale in Soggetti Sani e in Pazienti Con Patologie Retino-coroideali
The purpose of this prospective, longitudinal, single-center observational study is to identify, describe, and measure the morpho-functional characteristics and modifications of the retina and choroid using advanced multimodal imaging techniques. The study will evaluate patients affected by retino-choroidal diseases and compare them with healthy controls over a 5-year follow-up period to track the evolution of these parameters over time.
- Conditions
- Retinal Diseases, Choroidal Diseases, Healthy Subjects
- Medical subject headings
- Retinal Diseases, Choroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Retino-Choroidal Diseases | Subjects of any gender, aged 6 years or older, diagnosed with any type of retino-choroidal pathology. Participants in this cohort will undergo multi-device structural and functional retinal/choroidal imaging monitoring over a 5-year follow-up period. | |
| Healthy Controls | Healthy subjects of any gender, aged 6 years or older, who do not present with any active or historical retino-choroidal pathology. This group serves as a baseline comparison to evaluate normal morpho-functional retinal and choroidal trajectories over the 5-year study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in retinal thickness measured by OCT
Change in retinal thickness from baseline to each follow-up visit, measured by optical coherence tomography (OCT). Retinal thickness will be reported in micrometers (µm), including central macular thickness and/or retinal layer thicknesses, as applicable.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Secondary outcomes (5)
Change from baseline in choroidal thickness measured by OCT
Change in choroidal thickness from baseline to each follow-up visit, measured by OCT and reported in micrometers (µm).
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal and/or choroidal vascular density measured by OCTA
Change in vascular parameters assessed by OCT angiography, including perfusion density, vessel length density, FAZ area, and/or choriocapillaris flow deficit, reported according to the specific metric generated by the device or analysis software
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal sensitivity measured by microperimetry
Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in cone density measured by adaptive optics
Change in cone density assessed by adaptive optics imaging and reported as cones/mm²
Measured: Baseline, 12, 24, 36, 48, and 60 months
Change from baseline in qualitative retinal and choroidal imaging features
Qualitative changes in retinal and choroidal morphology, reflectivity, autofluorescence patterns, and ultra-widefield retinal features, assessed by expert ophthalmologists using multimodal imaging.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startOct 2026 (estimated)
- Primary completion1 Jun 2033 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 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
- NCT07615699
- Sponsor's protocol ID
- RET 05-26
- Acronym
- RET 05-26
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Morfo-funzionale Della Retina e Della Coroide Mediante Imaging Multimodale in Soggetti Sani e in Pazienti Con Patologie Retino-coroideali
- ClinicalTrials.gov ID
- NCT07615699
- Acronym / sponsor ID
- RET 05-26 / RET 05-26
- Conditions
- Retinal Diseases, Choroidal Diseases, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 Jun 2033 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 29 May 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.
The purpose of this prospective, longitudinal, single-center observational study is to identify, describe, and measure the morpho-functional characteristics and modifications of the retina and choroid using advanced multimodal imaging techniques. The study will evaluate patients affected by retino-choroidal diseases and compare them with healthy controls over a 5-year follow-up period to track the evolution of these parameters over time.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Retino-Choroidal Diseases | – | –Subjects of any gender, aged 6 years or older, diagnosed with any type of retino-choroidal pathology. Participants in this cohort will undergo multi-device structural and functional retinal/choroidal imaging monitoring over a 5-year follow-up period. |
| Healthy Controls | – | –Healthy subjects of any gender, aged 6 years or older, who do not present with any active or historical retino-choroidal pathology. This group serves as a baseline comparison to evaluate normal morpho-functional retinal and choroidal trajectories over the 5-year study period. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of both healthy volunteers and patients diagnosed with any type of retino-choroidal pathology. Participants will be selected from individuals who routinely attend or are referred to the outpatient clinics at the IRCCS Fondazione G. B. Bietti in Rome, Italy. The sample is designed to include a wide age range (age ≥ 6 years old) to capture the natural progression and morpho-functional characteristics of these conditions across different demographics. The cohort will feature a 4:1 allocation ratio, comprising 100 patients with retino-choroidal diseases and 25 age- and sex-matched healthy controls to ensure adequate statistical power for longitudinal progression analysis.
Key inclusion criteria (5 listed)
- freely given informed consent acquired prior to the start of the study.
- Participant's capacity to understand the informed consent and study procedures.
- Age ≥ 6 years (with parental/guardian consent for minors).
- Patients affected by any retino-choroidal disease.
- Healthy subjects showing no retino-choroidal pathology.
Key exclusion criteria (2 listed)
- Patient unable and/or unwilling to cooperate.
- Presence of media opacities (dioptric media) that prevent image acquisition or significantly reduce the quality of the obtained images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in retinal thickness measured by OCT
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Change in retinal thickness from baseline to each follow-up visit, measured by optical coherence tomography (OCT). Retinal thickness will be reported in micrometers (µm), including central macular thickness and/or retinal layer thicknesses, as applicable.
5 secondary outcomes
Change from baseline in choroidal thickness measured by OCT
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal and/or choroidal vascular density measured by OCTA
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal sensitivity measured by microperimetry
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in cone density measured by adaptive optics
Time frame: Baseline, 12, 24, 36, 48, and 60 months
Change from baseline in qualitative retinal and choroidal imaging features
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
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 4 Sep 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.
Costanzo contact
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Diseases and Choroidal Diseases, run by Fondazione G.B. Bietti, IRCCS.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Parravano (0684009442, mariacristina.parravano@fondazionebietti.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in retinal thickness measured by OCT (time frame: Baseline, 12, 24, 36, 48, and 60 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 4 Sep 2026.