Macular Degeneration Choroidal NeovascularizationOCTANCT05969418
Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC
An observational study of Macular Degeneration Choroidal Neovascularization, run by Federico II University at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration Choroidal Neovascularization
- What is being tested?
- Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 21 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease
Who may be able to join
- 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
Who cannot join
- previous retinal surgery and congenital eye diseases
- errors of refraction
- lens opacities
- low-quality OCT and OCTA images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration
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.
- Being tested
- Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameterDiagnostic test
Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with neovascular macular degeneration | Not described Receives: 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 | Not described Receives: Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc
Measured: more than sixmonths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2023
- Primary completion20 Jul 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration Choroidal NeovascularizationStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Ciro Costagliola, MD, Study chair, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969418
- Sponsor's protocol ID
- 05809850
- Acronym
- OCTA
- Status last verified
- May 2024
- First submitted
- 23 Jul 2023
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05969418
- Acronym / sponsor ID
- OCTA / 05809850
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 1 Aug 2023 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- previous retinal surgery and congenital eye diseases
- errors of refraction
- lens opacities
- low-quality OCT and OCTA images
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 |
|---|---|---|
| Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameterDiagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment | Diagnostic test | Patients with neovascular macular degeneration, healty patients matched age and sex without any ocular disease |
Primary outcome
The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc
Time frame: more than sixmonths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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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. This study is not recruiting at the moment.
Ciro Costagliola, MD study chair
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration Choroidal Neovascularization, run by Federico II University 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc (time frame: more than sixmonths). 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 22 May 2024.