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

Macular Degeneration Exudative Eye Left Clinical Trial

— QUAOBARE  

Official title:

OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939195
• Other study ID #: QUAOBARE
• Secondary ID: 2018-A00948-47
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 also on quantified quantitative and objective values.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Macular Degeneration Exudative Eye Left
• Macular Degeneration Exudative Eye Right
• Wet Macular Degeneration

Intervention

Other:
• Follow-up
4 follow-up visits with OCT Angiography and Structural OCT B

Locations

Country	Name	City	State
France	CHI Créteil	Créteil
France	Centre Bergouignan	Évreux
France	Centre d'exploration ophtalmologique de l'odéon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

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