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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03939195

Recruitment Status Completed

First Posted May 6, 2019

Last update posted July 9, 2020

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:Macular Degeneration Exudative Eye Left
    Macular Degeneration Exudative Eye Right
  • Intervention/Treatment: Other: Follow-up
  • Phase: N/A
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: December 2018
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: July 2020
Outcome Measures
  • 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 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
  • 2. 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
  • 3. 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
  • 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
  • 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
Contacts
Locations

France
CHI Créteil
Créteil

France
Centre d'exploration ophtalmologique de l'odéon
Paris

France
Centre Bergouignan
Évreux

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

More Information
  • Responsible Party: Centre Hospitalier Intercommunal Creteil
  • ClinicalTrials.gov Identifier: NCT03939195 History of Changes
  • Other Study ID Numbers: QUAOBARE, 2018-A00948-47
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Macular Degeneration Wet Macular Degeneration