Choroidal NeovascularizationNCT05055973
OCTA Insights in CNVM, Morphological Characteristics and Correlation With Structural OCT.
An observational study of Choroidal Neovascularization, run by Assiut University.
Trial summary
To suggest a novel classification of choroidal neovascular membrane based on optical coherence tomography angiography and to correlate morphological characteristics based on optical coherence tomography with clinical criteria of disease activity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Neovascularization
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with choroidal neovascular membrane, naive or previously treated.
Who may be able to join
- Patients with all types of CNV, previously treated or naïve.
Who cannot join
- The presence of prominent media opacity.
- Significant cataract.
- Poor fixation.
- Any other factor that interferes with obtaining good-quality OCT/OCTA images.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optical Coherence Tomography Angiography Insights in Choroidal Neovascular Membrane, Morphological Characteristics and Correlation With Structural Optical Coherence Tomography.
To suggest a novel classification of choroidal neovascular membrane based on optical coherence tomography angiography and to correlate morphological characteristics based on optical coherence tomography with clinical criteria of disease activity.
Read the detailed description
Choroidal neovascularization is an important path biologic mechanism encountered in a variety of chorio-retinal diseases. Choroidal neo-vascularization represents new blood vessel growth from the choroid that extends into the sub-retinal pigment epithelium, or sub-retinal space, or a combination of both. There is some evidence that the clinical findings and angiographic appearance of choroidal neo-vascular membrane correlate with the growth pattern. Choroidal neo- vascularization dynamic evolution includes initiation, inflammatory active, and inflammatory inactive stages.
It can be assumed that there is a risk of choroidal neo-vascular membrane development in any case where the integrity of Bruch's membrane or the retinal pigment epithelium is impaired. The most common cause of choroidal neo-vascular membrane is indisputably age-related macular degeneration, but choroidal neo-vascular membrane may also occur secondary to many other etiologies, such as pathological myopia, angioid streaks, uveitis, infection, and traumatic Bruch's membrane-retinal pigment epithelium defects, and idiopathic cases where no etiology can be detected.
Growth pattern:
Although no two choroidal neo-vascular membrane growth patterns are exactly alike, choroidal neo-vascular membrane grows in the plane between the retinal pigment epithelium and the Bruch membrane, between the retina and retinal pigment epithelium, or a combination of both (combined pattern). There is a retinal vascular contribution in approximately 6% of choroidal neo-vascular membrane . The new blood vessels are capillary-like and, with time, become arterial and venular.
Imaging modalities:
Fundus fluorescein angiography with dye injection is considered the gold standard for detecting choroidal neo-vascular membrane and assessing its activity. However, Fundus fluorescein angiography is time consuming and invasive, resulting in varying degrees of patient discomfort, including anaphylactic reactions that can occur during and/or after fundus fluorescein angiography. A total of 4.8% patients were reported to have experienced adverse events after the fundus fluorescein angiography, including nausea (2.9%), vomiting (1.2%), and flushing/itching (0.5%).
Optical coherence tomography has become an important non-invasive and quick method to diagnose and monitor disease activity during anti- vascular endothelial growth factor treatment by revealing the fate of active choroidal neo-vascular membrane such as intra- and sub-retinal fluid accumulation and retinal thickening. On optical coherence tomography CNV appears as sub-retinal or sub-retinal pigment epithelium hyper reflective material with limited differentiation between unreactive fibrous and/or active neo-vascular tissue. Retreatment decisions are mainly based on assessment of extravascular fluid and not on an analysis of neo-vascular activity.
Optical coherence tomography angiography offers a breakthrough in diagnostic imaging by allowing non-invasive visualization of retinal and choroidal vascular flow via motion-contrast imaging. Optical coherence tomography angiography provides depth-resolved visualization of the retinal and choroidal vasculature without the need for dye injection. The technology has been applied for the diagnosis and monitoring of choroidal neo-vascular membrane in age-related macular degeneration. Optical coherence tomography angiography has described features of myopic choroidal neo-vascular membrane and demonstrated its high sensitivity and specificity for neo-vascular detection. Optical coherence tomography angiography is a new noninvasive imaging modality, based on high-frequency scanning for the detection of blood cell movement. This imaging modality takes advantage of the optical coherence tomography capacity to generate images by measuring the amplitude and delay of reflected and backscattered light. Multiple repeated scans are carried out in the same retinal location, and the images obtained are compared to identify the signal differences between two consecutive scans. Because the retina is a static structure, it is reasonable to suppose that these changes are imputable to the blood flow. This precise and non-invasive imaging modality offers novel diagnostic opportunities to fill the current gap between invasive vascular and non- invasive structural imaging.
- Conditions
- Choroidal Neovascularization
- Medical subject headings
- Choroidal Neovascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological characters of choroidal neovascular membrane
To describe morphological criteria of choroidal neovascular membrane using optical coherence tomography angiography (OCTA).
Measured: One year
Secondary outcomes (1)
Correlation between morphological characters of choroidal neovascular membrane and disease activity
To correlate the morphological characters of choroidal neovascular membrane and clinical criteria of disease activity
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mahmoud A. Abdallah, Assiut University
- Investigators
- Samir Y Saleh, PhD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055973
- Sponsor's protocol ID
- OCTAIICNMMCACWSOCT
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corvi F, Cozzi M, Barbolini E, Nizza D, Belotti M, Staurenghi G, Giani A. COMPARISON BETWEEN SEVERAL OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES AND INDOCYANINE GREEN ANGIOGRAPHY OF CHOROIDAL NEOVASCULARIZATION. Retina. 2020 May;40(5):873-880. doi: 10.1097/IAE.0000000000002471.
PubMed 30807517Parravano M, Querques L, Scarinci F, Giorno P, De Geronimo D, Gattegna R, Varano M, Bandello F, Querques G. Optical coherence tomography angiography in treated type 2 neovascularization undergoing monthly anti-VEGF treatment. Acta Ophthalmol. 2017 Aug;95(5):e425-e426. doi: 10.1111/aos.13180. Epub 2016 Aug 6. No abstract available.
PubMed 27496070Grossniklaus HE, Green WR. Choroidal neovascularization. Am J Ophthalmol. 2004 Mar;137(3):496-503. doi: 10.1016/j.ajo.2003.09.042.
PubMed 15013874Querques G, Corvi F, Querques L, Souied EH, Bandello F. Optical Coherence Tomography Angiography of Choroidal Neovascularization Secondary to Pathologic Myopia. Dev Ophthalmol. 2016;56:101-6. doi: 10.1159/000442800. Epub 2016 Mar 15.
PubMed 27023343
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Insights in Choroidal Neovascular Membrane, Morphological Characteristics and Correlation With Structural Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT05055973
- Acronym / sponsor ID
- OCTAIICNMMCACWSOCT
- Conditions
- Choroidal Neovascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Sep 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.
To suggest a novel classification of choroidal neovascular membrane based on optical coherence tomography angiography and to correlate morphological characteristics based on optical coherence tomography with clinical criteria of disease activity.
Detailed description
Choroidal neovascularization is an important path biologic mechanism encountered in a variety of chorio-retinal diseases. Choroidal neo-vascularization represents new blood vessel growth from the choroid that extends into the sub-retinal pigment epithelium, or sub-retinal space, or a combination of both. There is some evidence that the clinical findings and angiographic appearance of choroidal neo-vascular membrane correlate with the growth pattern. Choroidal neo- vascularization dynamic evolution includes initiation, inflammatory active, and inflammatory inactive stages.
It can be assumed that there is a risk of choroidal neo-vascular membrane development in any case where the integrity of Bruch's membrane or the retinal pigment epithelium is impaired. The most common cause of choroidal neo-vascular membrane is indisputably age-related macular degeneration, but choroidal neo-vascular membrane may also occur secondary to many other etiologies, such as pathological myopia, angioid streaks, uveitis, infection, and traumatic Bruch's membrane-retinal pigment epithelium defects, and idiopathic cases where no etiology can be detected.
Growth pattern:
Although no two choroidal neo-vascular membrane growth patterns are exactly alike, choroidal neo-vascular membrane grows in the plane between the retinal pigment epithelium and the Bruch membrane, between the retina and retinal pigment epithelium, or a combination of both (combined pattern). There is a retinal vascular contribution in approximately 6% of choroidal neo-vascular membrane . The new blood vessels are capillary-like and, with time, become arterial and venular.
Imaging modalities:
Fundus fluorescein angiography with dye injection is considered the gold standard for detecting choroidal neo-vascular membrane and assessing its activity. However, Fundus fluorescein angiography is time consuming and invasive, resulting in varying degrees of patient discomfort, including anaphylactic reactions that can occur during and/or after fundus fluorescein angiography. A total of 4.8% patients were reported to have experienced adverse events after the fundus fluorescein angiography, including nausea (2.9%), vomiting (1.2%), and flushing/itching (0.5%).
Optical coherence tomography has become an important non-invasive and quick method to diagnose and monitor disease activity during anti- vascular endothelial growth factor treatment by revealing the fate of active choroidal neo-vascular membrane such as intra- and sub-retinal fluid accumulation and retinal thickening. On optical coherence tomography CNV appears as sub-retinal or sub-retinal pigment epithelium hyper reflective material with limited differentiation between unreactive fibrous and/or active neo-vascular tissue. Retreatment decisions are mainly based on assessment of extravascular fluid and not on an analysis of neo-vascular activity.
Optical coherence tomography angiography offers a breakthrough in diagnostic imaging by allowing non-invasive visualization of retinal and choroidal vascular flow via motion-contrast imaging. Optical coherence tomography angiography provides depth-resolved visualization of the retinal and choroidal vasculature without the need for dye injection. The technology has been applied for the diagnosis and monitoring of choroidal neo-vascular membrane in age-related macular degeneration. Optical coherence tomography angiography has described features of myopic choroidal neo-vascular membrane and demonstrated its high sensitivity and specificity for neo-vascular detection. Optical coherence tomography angiography is a new noninvasive imaging modality, based on high-frequency scanning for the detection of blood cell movement. This imaging modality takes advantage of the optical coherence tomography capacity to generate images by measuring the amplitude and delay of reflected and backscattered light. Multiple repeated scans are carried out in the same retinal location, and the images obtained are compared to identify the signal differences between two consecutive scans. Because the retina is a static structure, it is reasonable to suppose that these changes are imputable to the blood flow. This precise and non-invasive imaging modality offers novel diagnostic opportunities to fill the current gap between invasive vascular and non- invasive structural imaging.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with choroidal neovascular membrane, naive or previously treated.
Key inclusion criteria (1 listed)
- Patients with all types of CNV, previously treated or naïve.
Key exclusion criteria (4 listed)
- The presence of prominent media opacity.
- Significant cataract.
- Poor fixation.
- Any other factor that interferes with obtaining good-quality OCT/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.
Primary outcome
Morphological characters of choroidal neovascular membrane
Time frame: One year
To describe morphological criteria of choroidal neovascular membrane using optical coherence tomography angiography (OCTA).
1 secondary outcome
Correlation between morphological characters of choroidal neovascular membrane and disease activity
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Results publication: PubMed 30807517Corvi F, Cozzi M, Barbolini E, Nizza D, Belotti M, Staurenghi G, Giani A. COMPARISON BETWEEN SEVERAL OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES AND INDOCYANINE GREEN ANGIOGRAPHY OF CHOROIDAL NEOVASCULARIZATION. Retina. 2020 May;40(5):873-880. doi: 10.1097/IAE.0000000000002471.
- Results publication: PubMed 27496070Parravano M, Querques L, Scarinci F, Giorno P, De Geronimo D, Gattegna R, Varano M, Bandello F, Querques G. Optical coherence tomography angiography in treated type 2 neovascularization undergoing monthly anti-VEGF treatment. Acta Ophthalmol. 2017 Aug;95(5):e425-e426. doi: 10.1111/aos.13180. Epub 2016 Aug 6. No abstract available.
- Results publication: PubMed 15013874Grossniklaus HE, Green WR. Choroidal neovascularization. Am J Ophthalmol. 2004 Mar;137(3):496-503. doi: 10.1016/j.ajo.2003.09.042.
- Results publication: PubMed 27023343Querques G, Corvi F, Querques L, Souied EH, Bandello F. Optical Coherence Tomography Angiography of Choroidal Neovascularization Secondary to Pathologic Myopia. Dev Ophthalmol. 2016;56:101-6. doi: 10.1159/000442800. Epub 2016 Mar 15.
- 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. This study is not recruiting at the moment.
Samir Y Saleh, PhD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Neovascularization, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samir Y Saleh, PhD (01003304320 ext. +2, samir.abouelail@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological characters of choroidal neovascular membrane (time frame: One year). 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 NCT05055973, which also lists 4 linked publications.
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 24 Sep 2021.