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Choroidal NeovascularizationNCT05055973

OCTA Insights in CNVM, Morphological Characteristics and Correlation With Structural OCT.

An observational study of Choroidal Neovascularization, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Medical subject headings
Choroidal Neovascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted24 Sep 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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)
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 30807517
  • Parravano 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 27496070
  • Grossniklaus HE, Green WR. Choroidal neovascularization. Am J Ophthalmol. 2004 Mar;137(3):496-503. doi: 10.1016/j.ajo.2003.09.042.

    PubMed 15013874
  • Querques 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

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.

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