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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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
How many people
200 participants
Where
No sites listed yet
Study dates
Jan 2026to May 2028
Phase
Observational

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.

Alessandro Arrigo, MD, PhD contact

+390226432648

arrigo.alessandro@hsr.it

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.

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 groups in NCT07298174
Study groupRoleWhat they receive
Patients affected by ocular diseasesPatients 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.

  1. Retinal vessel density

    Quantitative analysis of macular and peripheral capillary perfusion

    Measured: Cross-sectional investigation at baseline and after 1-year follow-up

  2. 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.

  1. First posted23 Dec 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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)
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

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