Macular Degeneration Exudative Eye LeftQUAOBARENCT03939195
OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration)
An observational study of Macular Degeneration Exudative Eye Left and Macular Degeneration Exudative Eye Right, run by Centre Hospitalier Intercommunal Creteil at 3 sites in France.
Trial summary
The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration Exudative Eye Left, Macular Degeneration Exudative Eye Right
- What is being tested?
- Follow-up
- How many people
- 130 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2018to 1 Jul 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be proposed to patients for whom intravitreal injections have already been performed for AMD-related choroidal neovascular vessels according to inclusion criteria over a period of four visits to TAE during the second year of therapeutic observation.
Who may be able to join
- Man / woman over 50,
- Showing type 1 or type 2 CNV (choroidal neovessel) related to AMD during the second year of follow-up.
- Acceptance to participate in the protocol
- Affiliated to a social security scheme
Who cannot join
- Type III CNV related to AMD,
- Other cause of CNV
- Signal less than 80 decibel and detachment of pigment epithelium (PED) greater than 250 μm on structural OCT B.
- Protected Majors (Guardianship, Curator, Safeguard of Justice)
- Participation in another interventional research.
- Refusal to participate in the study
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHI Créteil
Créteil, 94000
Centre Bergouignan
Évreux, 27000
Centre d'exploration ophtalmologique de l'odéon
Paris
About this study
Official title: OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD
The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.
Read the detailed description
This quantification is based on the analysis of fractal dimension (FD, without unit), lacunarity (Lac, without unit), vascular density (VD,%) and surface area of choroidal neovascular ( CNV, mm2).
The fractal dimension of a vascular structure corresponds to its degree of complexity. Fractals are models found in nature and biological systems that show self-similarity at different magnifications. It is obtained from the "box counting" method calculating the number of vascular segments contained in squares of varied size. Normal retinal vessels have a known and quantified complexity (FD = 1.7).
A neovascular tumor treated with anti-angiogenics will reduce vascular density, losing its random architecture; the investigators observe a return to a model standardized. NVCs have a random organization. The lower the FD, the more random the vascular architecture.
Lacunarity represents the texture or the homogeneity of a lesion, this one is heterogeneous when it is little vascularized and homogeneous if the vascularization is very dense. The lower the lake, the more homogeneous the lesion.
FD and Lac are obtained in Angiography Optical Coherence Tomography (OCTA) by the analysis of the hypersignal detected on the cut of the external retina.
The image is automatically binarised and skeletonized. NVC delineation is automatic and associated with automatic background noise processing. This software is fully automatic whose inter and intra grader reproducibility will be evaluated.
- Being tested
- Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
4 follow-up visits with OCT Angiography and Structural OCT B
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractal dimension (without unit)
Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.
Measured: 12 months
Fractal lacunarity (without unit)
Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.
Measured: 12 months
Vascular density (%)
Analysis of vascular density measured by OCT-A on 4 consecutive examinations.
Measured: 12 months
Vascular surface (micronm2)
Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.
Measured: 12 months
Secondary outcomes (4)
Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status
Investigation of a relationship between fractal dimension mesured on OCT-A and the status of choroidal neovessels
Measured: 12 months
Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status
Investigation of a relationship between fractal lacunarity and the status of choroidal neovessels
Measured: 12 months
Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status
Investigation of a relationship between vascula density and the status of choroidal neovessels
Measured: 12 months
Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status
Investigation of a relationship between vascular surface and the status of choroidal neovessels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Dec 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration Exudative Eye LeftStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939195
- Sponsor's protocol ID
- QUAOBARE
- Other IDs
- 2018-A00948-47
- Acronym
- QUAOBARE
- Status last verified
- Jul 2020
- First submitted
- 11 Jan 2019
- Last updated
- 9 Jul 2020
- 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 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD
- ClinicalTrials.gov ID
- NCT03939195
- Acronym / sponsor ID
- QUAOBARE / QUAOBARE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 6 May 2019 (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 objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.
Detailed description
This quantification is based on the analysis of fractal dimension (FD, without unit), lacunarity (Lac, without unit), vascular density (VD,%) and surface area of choroidal neovascular ( CNV, mm2).
The fractal dimension of a vascular structure corresponds to its degree of complexity. Fractals are models found in nature and biological systems that show self-similarity at different magnifications. It is obtained from the "box counting" method calculating the number of vascular segments contained in squares of varied size. Normal retinal vessels have a known and quantified complexity (FD = 1.7).
A neovascular tumor treated with anti-angiogenics will reduce vascular density, losing its random architecture; the investigators observe a return to a model standardized. NVCs have a random organization. The lower the FD, the more random the vascular architecture.
Lacunarity represents the texture or the homogeneity of a lesion, this one is heterogeneous when it is little vascularized and homogeneous if the vascularization is very dense. The lower the lake, the more homogeneous the lesion.
FD and Lac are obtained in Angiography Optical Coherence Tomography (OCTA) by the analysis of the hypersignal detected on the cut of the external retina.
The image is automatically binarised and skeletonized. NVC delineation is automatic and associated with automatic background noise processing. This software is fully automatic whose inter and intra grader reproducibility will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be proposed to patients for whom intravitreal injections have already been performed for AMD-related choroidal neovascular vessels according to inclusion criteria over a period of four visits to TAE during the second year of therapeutic observation.
Key inclusion criteria (4 listed)
- Man / woman over 50,
- Showing type 1 or type 2 CNV (choroidal neovessel) related to AMD during the second year of follow-up.
- Acceptance to participate in the protocol
- Affiliated to a social security scheme
Key exclusion criteria (6 listed)
- Type III CNV related to AMD,
- Other cause of CNV
- Signal less than 80 decibel and detachment of pigment epithelium (PED) greater than 250 μm on structural OCT B.
- Protected Majors (Guardianship, Curator, Safeguard of Justice)
- Participation in another interventional research.
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 |
|---|---|---|
| Follow-up4 follow-up visits with OCT Angiography and Structural OCT B | Other | – |
Primary outcome
Fractal dimension (without unit)
Time frame: 12 months
Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.
Fractal lacunarity (without unit)
Time frame: 12 months
Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.
Vascular density (%)
Time frame: 12 months
Analysis of vascular density measured by OCT-A on 4 consecutive examinations.
Vascular surface (micronm2)
Time frame: 12 months
Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.
4 secondary outcomes
Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status
Time frame: 12 months
Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status
Time frame: 12 months
Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status
Time frame: 12 months
Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status
Time frame: 12 months
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 9 Jul 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Exudative Eye Left and Macular Degeneration Exudative Eye Right, run by Centre Hospitalier Intercommunal Creteil at 3 sites 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 4 inclusion and 6 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Fractal dimension (without unit) (time frame: 12 months). The study lists 4 primary outcomes in all. 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 9 Jul 2020.