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CompletedNCT05969418OCTAUpdated May 22, 2024

Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC

An observational study in Macular Degeneration Choroidal Neovascularization, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
50 Years to 90 Years
Sex
All
01

Study summary

To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.

Read the detailed description

Exudative neovascular macular degeneration is the primarily an age-related retinal condition The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features in order to choose the best therapy .

The study evaluates the changes in structural optical coherence tomography and optical coherence tomography angiography features in neovascular macular degeration patients undergoing ANTI-VEGF treatments using artificial intelligence.

02

Conditions studied

  • Macular Degeneration Choroidal Neovascularization
03

In context

Choroidal Neovascularization

214 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.

This study's enrollment of 50 is below the median of 79 across 42 observational studies indexed under Choroidal Neovascularization.

Browse Choroidal Neovascularization studies →

Lead sponsor

Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease

Eligibility criteria

Inclusion Criteria: age older than 50 years

  • diagnosis of neovascular macular degeneration
  • absence of previous retinal surgery and congenital eye diseases.
  • absence of errors of refraction
  • absence of lens opacities
  • absence of low-quality OCT and OCTA images

Exclusion Criteria:• age younger than 50 years

  • previous retinal surgery and congenital eye diseases
  • errors of refraction
  • lens opacities
  • low-quality OCT and OCTA images
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with neovascular macular degeneration

    Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter

  • healty patients matched age and sex without any ocular disease

    Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter

Interventions

  • Diagnostic testDiagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter

    Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment

06

What researchers measure

Primary outcomes

  1. The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc

    Time frame: more than sixmonths

07

Study locations

1 site
  • Federico II University
    Naples, 80121, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Jul 2023, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2023
First posted
Aug 1, 2023
StartActual
Jul 1, 2023
Primary completionActual
Jul 20, 2023
CompletionActual
Dec 21, 2023
Last update
May 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05969418
Responsible party
Gilda Cennamo (Doctor, Federico II University) — Principal investigator
First posted
Aug 1, 2023
Start date
Jul 1, 2023
Primary completion
Jul 20, 2023
Completion
Dec 21, 2023
Last update
May 22, 2024

Study contacts

Ciro Costagliola, MD
study chair · Federico II University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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