AMD - Age-Related Macular DegenerationNCT07143526
Comparison of the Sensibility of Swept Source Optical Coherence Tomography Devices in the Detection of Neovascularisation in Large Pigment Epithelium Detachments
An observational study of AMD - Age-Related Macular Degeneration, run by University of Trieste at 1 site in France.
Trial summary
The goal of this observational study is to compare swept source optical coherence tomography devices ability to detect macular neovascularisation when there is a large pigment epithelium detachment higher than 250 microns Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AMD - Age-Related Macular Degeneration
- What is being tested?
- Optical Coherence Tomography Angiography (OCT-A)
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2025to Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for neovascular age related macular degeneration (AMD)
Who may be able to join
- Patients treated for neovascular age related macular degeneration (AMD)
- Presence of a pigmentary epithelium detachment higher than 250 microns measured on structural optical coherence tomography (OCT)
Who cannot join
- Poor image quality or signal strength
- Undefined retina layers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Intercommunal de Créteil
Créteil, Val De Marne, 94000
Kamal El Majdoubi El Idrissi, Medical Doctor, +33780410459, majkamal1995@gmail.com
About this study
Official title: Comparison of Two Swept-source Optical Coherence Tomography Angiography (OCTA) Devices (Bmizar and Plexelite) for Detecting Macular Neovascularisation With Large (More Than 250 Microns) Pigment Epithelium Detachment (PED) in Age Related Macular Degeneration
The goal of this observational study is to compare swept source optical coherence tomography devices ability to detect macular neovascularisation when there is a large pigment epithelium detachment higher than 250 microns
- Conditions
- AMD - Age-Related Macular Degeneration
- Being tested
- Optical Coherence Tomography Angiography (OCT-A)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography Angiography (OCT-A)Diagnostic test
Two Optical Coherence Tomography Angiography swept source devices are compared for the detection of large pigment epithelium detachments in age related macular degeneration. The sensitivity of the devices is compared in both the automatic segmentation done by the device and the manual segmentation done by a retina specialist.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devices
The optical coherence tomography angiography devices are known to have a difficult time detecting neovascularisation in the cases of large pigment epithelium detachments (PED), because of the many layers and the distance the OCT signal has to cross. The automatic retina segmentation (done by the device of the different retina layers plays a big role in this detection. It's also disturbed by the height of the PED.
This study aims to compare the sensitivity of two swept source OCT devices available in the market : Bmizar, Towardpi and Plexelite, Zeiss.
After the exam image acquisition, a retina specialist will try to make a manual segmentation of the retina analysed to help the detection of macular neovascularisation that would have been missed in the "normal" automatic segmentation done by the device.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMD - Age-Related Macular DegenerationStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Rocco Pastore, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143526
- Sponsor's protocol ID
- 1030725
- Status last verified
- Jul 2025
- First submitted
- 11 Aug 2025
- Last updated
- 27 Aug 2025
- 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Swept-source Optical Coherence Tomography Angiography (OCTA) Devices (Bmizar and Plexelite) for Detecting Macular Neovascularisation With Large (More Than 250 Microns) Pigment Epithelium Detachment (PED) in Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07143526
- Acronym / sponsor ID
- 1030725
- Conditions
- AMD - Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Aug 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 goal of this observational study is to compare swept source optical coherence tomography devices ability to detect macular neovascularisation when there is a large pigment epithelium detachment higher than 250 microns
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for neovascular age related macular degeneration (AMD)
Key inclusion criteria (2 listed)
- Patients treated for neovascular age related macular degeneration (AMD)
- Presence of a pigmentary epithelium detachment higher than 250 microns measured on structural optical coherence tomography (OCT)
Key exclusion criteria (2 listed)
- Poor image quality or signal strength
- Undefined retina layers
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 |
|---|---|---|
| Optical Coherence Tomography Angiography (OCT-A)Two Optical Coherence Tomography Angiography swept source devices are compared for the detection of large pigment epithelium detachments in age related macular degeneration. The sensitivity of the devices is compared in both the automatic segmentation done by the device and the manual segmentation done by a retina specialist. | Diagnostic test | – |
Primary outcome
Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devices
Time frame: Day 1
The optical coherence tomography angiography devices are known to have a difficult time detecting neovascularisation in the cases of large pigment epithelium detachments (PED), because of the many layers and the distance the OCT signal has to cross. The automatic retina segmentation (done by the device of the different retina layers plays a big role in this detection. It's also disturbed by the height of the PED. This study aims to compare the sensitivity of two swept source OCT devices available in the market : Bmizar, Towardpi and Plexelite, Zeiss. After the exam image acquisition, a retina specialist will try to make a manual segmentation of the retina analysed to help the detection of macular neovascularisation that would have been missed in the "normal" automatic segmentation done by the device.
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 27 Aug 2025.
- 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.
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 AMD - Age-Related Macular Degeneration, run by University of Trieste at 1 site in France.
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 2 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 27 Aug 2025. 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 France. 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?
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 Kamal El Majdoubi El Idrissi, MD (+33780410459, majkamal1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devices (time frame: Day 1). 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 27 Aug 2025.