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OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration) (QUAOBARE)

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ClinicalTrials.gov Identifier: NCT03939195
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Study Description
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Brief 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 also on quantified quantitative and objective values.

Condition or disease Intervention/treatment
Macular Degeneration Exudative Eye Left Macular Degeneration Exudative Eye Right Other: Follow-up

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
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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2020

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Groups and Cohorts
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Intervention Details:
  • Other: Follow-up
    4 follow-up visits with OCT Angiography and Structural OCT B

Outcome Measures
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Primary Outcome Measures :
  1. Fractal dimension (without unit) [ Time Frame: 12 months ]
    Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.

  2. Fractal lacunarity (without unit) [ Time Frame: 12 months ]
    Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.

  3. Vascular density (%) [ Time Frame: 12 months ]
    Analysis of vascular density measured by OCT-A on 4 consecutive examinations.

  4. Vascular surface (micronm2) [ Time Frame: 12 months ]
    Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.


Secondary Outcome Measures :
  1. Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]
    Investigation of a relationship between fractal dimension mesured on OCT-A and the status of choroidal neovessels

  2. Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]
    Investigation of a relationship between fractal lacunarity and the status of choroidal neovessels

  3. Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]
    Investigation of a relationship between vascula density and the status of choroidal neovessels

  4. Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]
    Investigation of a relationship between vascular surface and the status of choroidal neovessels


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939195


Locations
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France
CHI Créteil
Créteil, France, 94000
Centre d'exploration ophtalmologique de l'odéon
Paris, France
Centre Bergouignan
Évreux, France, 27000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
More Information
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03939195    
Other Study ID Numbers: QUAOBARE
2018-A00948-47 ( Other Identifier: ID-RCB )
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases