Age - Related Macular Degeneration (AMD)WOOD-2025NCT07298174
Wide Field OCTA in Ocular Diseases
An observational study of Age - Related Macular Degeneration (AMD) and Diabetic Macular Edema, run by IRCCS San Raffaele.
Trial summary
The main retinal diseases, whether or not associated with specific mutations genetic, cause progressive degeneration of vascular retinal structures and not vascular, resulting in decreased visual function. Often, such diseases affect the noblest part of the retina, called macula. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age - Related Macular Degeneration (AMD), Diabetic Macular Edema, Diabetic Retinopathy
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to May 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by ocular diseases and healthy controls to be considered as reference.
Who may be able to join
- Age > 18 years
- Both genders
- Confirmed diagnosis of one of the above diseases
- Age-related macular degeneration
- Diabetic retinopathy
- Myopia
Show all 12Show fewer
- Pachychoroid spectrum disease
- Inherited retinal dystrophy
- Uveitis
- Dry eye
- Visual acuity of at least 1/20
- Signed informed consent for the participation to the trial.
Who cannot join
- Media opacities
- Any other eye or systemic condition that may irreversibly impair the results of the study
- Surgery in the eye in the study, including cataract extraction, in the three months prior to recruitment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Wide Field OCTA in Ocular Diseases: a Prospective Observational Study of the Clinical Impact of Wide Field OCTA in Ocular Disease.
The main retinal diseases, whether or not associated with specific mutations genetic, cause progressive degeneration of vascular retinal structures and not vascular, resulting in decreased visual function. Often, such diseases affect the noblest part of the retina, called macula. Many retinal diseases can be complicated by choroidal neovascularization which causes frequent bleeding and fluid leakage that accumulates in the subretinal and intraretinal spaces. Although the investigators know many details of each disease affecting the retina, very often the correct diagnostic framework can be complicated, given the presence of morphological elements common to the different pathologies. Similarly, predicting the effect of treatment and the patient's outcome is a constant challenge for the ophthalmologists. Most of the current research has been focused on the assessment of vascular alterations localized in the macula. However, growing evidence highlight the importance of peripheral vascular changes on the outcome of retinal diseases. These changes can be detected only be wide field OCT devices.
On the other hand, ocular inflammation and hyperemia represent major assessments in anterior segment disorders, such as dry eye disease. The current grading systems of ocular inflammation, redness and hyperemia are characterized by several limitations, thus making these evaluations still mainly confined to the subjective assessment performed by the ophthalmologist. However, the new generation OCT devices may include also an anterior segment module which can reconstruct anterior segment vessels, non-invasively, using the same technology described for retinal diseases.
The main goal of the study is to evaluate the diagnostic contribution of a new generation wide field OCTA device in ocular diseases, which has recently received CE marking. In particular, the investigators will evaluate this new generation device both in retinal and anterior segments diseases, testing for common points and differences with the standard of care non-invasive diagnostic devices. Secondary outcomes include the assessment of the correlation between the patient's visual function (visual acuity) and morphological changes (standard of care imaging assessment) highlighted by the wide field OCT device, with particular attention to microstructural differences between major ocular diseases and the possible development of non-invasive biomarkers, useful for the diagnosis and follow-up of such pathologies.
Read the detailed description
Hypothesis: wide field OCT may remarkably contribute on the improvement of diagnostic workup and precision medicine of ocular diseases.
Design: Post-market medical device, monocentric trial. Both cross-sectional and prospective.
The number of study groups and study duration: patients affected by ocular diseases (age-related macular degeneration, diabetic retinopathy, inherited retinal dystrophies, uveitis, myopia, pachychoroid spectrum, dry eye) and healthy controls. Duration 2-years.
the investigators will not expect remarkable biases since our evaluation will be based on the statistical analysis of quantitative imaging metrics coming from the investigational device and the comparator devices.
Both patients and controls will undergo complete ophthalmology assessment and non-invasive imaging diagnostic investigation.
In this study, the investigators will employ one standard-of-care device-Heidelberg Spectralis for retinal imaging and Keratograph 4M for anterior segment evaluation-alongside DreamOCT as the comparator device, replacing the second standard-of-care device typically used in our clinic. This is accepted and agrees with study design since, for diagnostic devices, the procedure to obtain CE approval includes safety check and comparability with other existing devices. Hence, the above described procedure represents the standard of care methodology when testing a novel device in clinical practice.
- Conditions
- Age - Related Macular Degeneration (AMD), Diabetic Macular Edema, Diabetic Retinopathy, Myopia, Inherited Retinal Disease, Stargardt Disease
- Keywords
- wide-field octa, multimodal retinal imaging, quantitative imaging, retinal disease, macular disease, ocular surface disease
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Myopia, Stargardt Disease, Retinitis Pigmentosa, Vitelliform Macular Dystrophy, Geographic Atrophy, Central Serous Chorioretinopathy
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 affected by ocular diseases | Patients affected by one of the following: AMD, diabetic retinopathy, pachychoroid spectrum, inherited retinal diseases, uveitis, ocular surface disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel density
Quantitative analysis of macular and peripheral capillary perfusion
Measured: Cross-sectional investigation at baseline and after 1-year follow-up
Conjunctival vessel density
Conjuctival perfusion in ocular surface diseases
Measured: Cross-sectional investigation at baseline and after 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Arrigo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298174
- Sponsor's protocol ID
- WOOD-2025
- Acronym
- WOOD-2025
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide Field OCTA in Ocular Diseases: a Prospective Observational Study of the Clinical Impact of Wide Field OCTA in Ocular Disease.
- ClinicalTrials.gov ID
- NCT07298174
- Acronym / sponsor ID
- WOOD-2025 / WOOD-2025
- Conditions
- Age - Related Macular Degeneration (AMD), Diabetic Macular Edema, Diabetic Retinopathy, Myopia, Inherited Retinal Disease, Stargardt Disease
- Keywords
- wide-field octa, multimodal retinal imaging, quantitative imaging, retinal disease, macular disease, ocular surface disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 23 Dec 2025 (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 main retinal diseases, whether or not associated with specific mutations genetic, cause progressive degeneration of vascular retinal structures and not vascular, resulting in decreased visual function. Often, such diseases affect the noblest part of the retina, called macula. Many retinal diseases can be complicated by choroidal neovascularization which causes frequent bleeding and fluid leakage that accumulates in the subretinal and intraretinal spaces. Although the investigators know many details of each disease affecting the retina, very often the correct diagnostic framework can be complicated, given the presence of morphological elements common to the different pathologies. Similarly, predicting the effect of treatment and the patient's outcome is a constant challenge for the ophthalmologists. Most of the current research has been focused on the assessment of vascular alterations localized in the macula. However, growing evidence highlight the importance of peripheral vascular changes on the outcome of retinal diseases. These changes can be detected only be wide field OCT devices.
On the other hand, ocular inflammation and hyperemia represent major assessments in anterior segment disorders, such as dry eye disease. The current grading systems of ocular inflammation, redness and hyperemia are characterized by several limitations, thus making these evaluations still mainly confined to the subjective assessment performed by the ophthalmologist. However, the new generation OCT devices may include also an anterior segment module which can reconstruct anterior segment vessels, non-invasively, using the same technology described for retinal diseases.
The main goal of the study is to evaluate the diagnostic contribution of a new generation wide field OCTA device in ocular diseases, which has recently received CE marking. In particular, the investigators will evaluate this new generation device both in retinal and anterior segments diseases, testing for common points and differences with the standard of care non-invasive diagnostic devices. Secondary outcomes include the assessment of the correlation between the patient's visual function (visual acuity) and morphological changes (standard of care imaging assessment) highlighted by the wide field OCT device, with particular attention to microstructural differences between major ocular diseases and the possible development of non-invasive biomarkers, useful for the diagnosis and follow-up of such pathologies.
Detailed description
Hypothesis: wide field OCT may remarkably contribute on the improvement of diagnostic workup and precision medicine of ocular diseases.
Design: Post-market medical device, monocentric trial. Both cross-sectional and prospective.
The number of study groups and study duration: patients affected by ocular diseases (age-related macular degeneration, diabetic retinopathy, inherited retinal dystrophies, uveitis, myopia, pachychoroid spectrum, dry eye) and healthy controls. Duration 2-years.
the investigators will not expect remarkable biases since our evaluation will be based on the statistical analysis of quantitative imaging metrics coming from the investigational device and the comparator devices.
Both patients and controls will undergo complete ophthalmology assessment and non-invasive imaging diagnostic investigation.
In this study, the investigators will employ one standard-of-care device-Heidelberg Spectralis for retinal imaging and Keratograph 4M for anterior segment evaluation-alongside DreamOCT as the comparator device, replacing the second standard-of-care device typically used in our clinic. This is accepted and agrees with study design since, for diagnostic devices, the procedure to obtain CE approval includes safety check and comparability with other existing devices. Hence, the above described procedure represents the standard of care methodology when testing a novel device in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by ocular diseases | – | –Patients affected by one of the following: AMD, diabetic retinopathy, pachychoroid spectrum, inherited retinal diseases, uveitis, ocular surface disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by ocular diseases and healthy controls to be considered as reference.
Key inclusion criteria (12 listed)
- Age > 18 years
- Both genders
- Confirmed diagnosis of one of the above diseases
- Age-related macular degeneration
- Diabetic retinopathy
Key exclusion criteria (3 listed)
- Media opacities
- Any other eye or systemic condition that may irreversibly impair the results of the study
- Surgery in the eye in the study, including cataract extraction, in the three months prior to recruitment
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
Retinal vessel density
Time frame: Cross-sectional investigation at baseline and after 1-year follow-up
Quantitative analysis of macular and peripheral capillary perfusion
Conjunctival vessel density
Time frame: Cross-sectional investigation at baseline and after 1-year follow-up
Conjuctival perfusion in ocular surface diseases
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 30 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Age - Related Macular Degeneration (AMD) and Diabetic Macular Edema, run by IRCCS San Raffaele.
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 12 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: opening soon, as of the sponsor's last update on 30 Dec 2025. 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 Alessandro Arrigo, MD, PhD (+390226432648, arrigo.alessandro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal vessel density (time frame: Cross-sectional investigation at baseline and after 1-year follow-up). The study lists 2 primary outcomes in all. 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 30 Dec 2025.