Clinical trial NCT03939195: OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration)
Official title: OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration Exudative Eye Left
Macular Degeneration Exudative Eye Right
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Fractal dimension (without unit)
timeFrame: 12 months
measure: Fractal lacunarity (without unit)
timeFrame: 12 months
measure: Vascular density (%)
timeFrame: 12 months
measure: Vascular surface (micronm2)
timeFrame: 12 months
Secondary outcomes:
measure: Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status
timeFrame: 12 months
measure: Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status
timeFrame: 12 months
measure: Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status
timeFrame: 12 months
measure: Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status
timeFrame: 12 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil
city: Paris
country: France
facility: Centre d'exploration ophtalmologique de l'odéon
city: Évreux
country: France
facility: Centre Bergouignan
Study officials:
References: