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

NCT03939195 | Completed

• 2 other identifiers: QUAOBARE2018-A00948-47
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Macular Degeneration Exudative Eye Left; Macular Degeneration Exudative Eye Right

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status

  12 months

• Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status

  12 months

• Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status

  12 months

• Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status

  12 months

Interventions

Follow-up OTHER

4 follow-up visits with OCT Angiography and Structural OCT B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (3)

CHI Créteil

Créteil, 94000, France

Location

Centre Bergouignan

Évreux, 27000, France

Location

Centre d'exploration ophtalmologique de l'odéon

Paris, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: May 6, 2019
• Study Start: December 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)