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

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration Exudative Eye Left; Macular Degeneration Exudative Eye Right
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • CHI Créteil
  • Paris, France
    • Centre D'exploration Ophtalmologique De L'odéon
  • Évreux, France, 27000
    • Centre Bergouignan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractal dimension (without unit)	Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.	12 months
Fractal lacunarity (without unit)	Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.	12 months
Vascular density (%)	Analysis of vascular density measured by OCT-A on 4 consecutive examinations.	12 months
Vascular surface (micronm2)	Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: QUAOBARE; 2018-A00948-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No