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

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Completed

CT.gov ID

NCT03939195

Collaborator

(none)

130

Enrollment

Locations

Actual Duration (Months)

43.3

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Dec 1, 2018

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2020

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status [12 months]
Investigation of a relationship between fractal dimension mesured on OCT-A and the status of choroidal neovessels
Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status [12 months]
Investigation of a relationship between fractal lacunarity and the status of choroidal neovessels
Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status [12 months]
Investigation of a relationship between vascula density and the status of choroidal neovessels
Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status [12 months]
Investigation of a relationship between vascular surface and the status of choroidal neovessels

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CHI Créteil	Créteil	France	94000
2	Centre d'exploration ophtalmologique de l'odéon	Paris	France
3	Centre Bergouignan	Évreux	France	27000

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT03939195

Other Study ID Numbers:

QUAOBARE
2018-A00948-47

First Posted:

May 6, 2019

Last Update Posted:

Jul 9, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Wet Macular Degeneration

Study Results

No Results Posted as of Jul 9, 2020