Macular NeovascularisationNCT05108285
Dark Halo and MNV: a Study Between ICGA and OCTA
An observational study of Macular Neovascularisation, run by Federico II University at 1 site in Italy.
Trial summary
The aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Macular Neovascularisation
- What is being tested?
- Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 15 Dec 2020
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A group of patients affected by MNV is subjected to OCTA and ICGA analysis in order to evaluate which of two methods is able to detect in a peculiar way the dark halo around the MNV
Who may be able to join
- age older than 55 years
- diagnosis of macular neovascularization
- absence of previous treatment with anti-Vegf injections
- absence of other retinal vascular diseases
Who cannot join
- age younger than 55 years
- absence diagnosis of macular neovascularization
- presence of previous treatment with anti-Vegf injections
- presence of other retinal vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dark Halo a New Biomarker in Macular Neovascularization: a Comparative Study Between ICGA and OCTA
The aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV
Read the detailed description
Dark halo is defined as a dark perilesional of flow decrease due to an area of reduced choroidal flow adjacent to the macular neovascularization (MNV).
The detection of MNV vascular details was only possible through invasive dye injection, such as fluorescein angiography (FA) or indocyanine green angiography (ICGA).
Optical coherence tomography angiography (OCTA) is a recent imaging technique that is able to detect the perfusion and non-perfusion areas carefully.
The aim of study is to compare the evaluation of dark halo area of MNV between ICGA and OCTA
- Conditions
- Macular Neovascularisation
- Being tested
- Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)Diagnostic test
OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN
| Study group | Role | What they receive |
|---|---|---|
| MNV group | Eyes affected by MNV. The dark halo of MNV was evaluated by OCTA and ICGA Receives: Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dark halo measurement
The OCTA and ICGA parameters analyzed are: the area of dark halo (mm2) that surrounds the coroidal neovascularization.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Jan 2018
- Primary completion1 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular NeovascularisationStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Gilda Cennamo, Principal investigator, Università Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108285
- Sponsor's protocol ID
- 9009/21
- Status last verified
- Nov 2021
- First submitted
- 24 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fossataro F, Cennamo G, Montorio D, Clemente L, Costagliola C. Dark halo, a new biomarker in macular neovascularization: comparison between OCT angiography and ICGA-a pilot prospective study. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3205-3211. doi: 10.1007/s00417-022-05693-8. Epub 2022 May 6.
PubMed 35522297
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dark Halo a New Biomarker in Macular Neovascularization: a Comparative Study Between ICGA and OCTA
- ClinicalTrials.gov ID
- NCT05108285
- Acronym / sponsor ID
- 9009/21
- Conditions
- Macular Neovascularisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 4 Nov 2021 (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 aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV
Detailed description
Dark halo is defined as a dark perilesional of flow decrease due to an area of reduced choroidal flow adjacent to the macular neovascularization (MNV).
The detection of MNV vascular details was only possible through invasive dye injection, such as fluorescein angiography (FA) or indocyanine green angiography (ICGA).
Optical coherence tomography angiography (OCTA) is a recent imaging technique that is able to detect the perfusion and non-perfusion areas carefully.
The aim of study is to compare the evaluation of dark halo area of MNV between ICGA and OCTA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MNV group | – | Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)Eyes affected by MNV. The dark halo of MNV was evaluated by OCTA and ICGA |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A group of patients affected by MNV is subjected to OCTA and ICGA analysis in order to evaluate which of two methods is able to detect in a peculiar way the dark halo around the MNV
Key inclusion criteria (4 listed)
- age older than 55 years
- diagnosis of macular neovascularization
- absence of previous treatment with anti-Vegf injections
- absence of other retinal vascular diseases
Key exclusion criteria (4 listed)
- age younger than 55 years
- absence diagnosis of macular neovascularization
- presence of previous treatment with anti-Vegf injections
- presence of other retinal vascular diseases
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 (OCTA) and indocyanine green angiography (ICGA)OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN | Diagnostic test | MNV group |
Primary outcome
Dark halo measurement
Time frame: three years
The OCTA and ICGA parameters analyzed are: the area of dark halo (mm2) that surrounds the coroidal neovascularization.
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 17 Nov 2021.
- Derived from this study: PubMed 35522297Fossataro F, Cennamo G, Montorio D, Clemente L, Costagliola C. Dark halo, a new biomarker in macular neovascularization: comparison between OCT angiography and ICGA-a pilot prospective study. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3205-3211. doi: 10.1007/s00417-022-05693-8. Epub 2022 May 6.
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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.
Gilda Cennamo principal investigator
Università Federico II
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 Neovascularisation, 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 4 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 17 Nov 2021. 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?
Dark halo measurement (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108285, which also lists 1 linked publication.
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 17 Nov 2021.