CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-04

Study Completion Date

2021-11-15

Brief Summary

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The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.

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Detailed Description

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Conditions

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AMD Exudative Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Naïve patients
* Type 1 or type 2 Choroidal NeoVascularization (CNV)
* Age ≥ 55 years
* Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
* At the time of inclusion, multimodal imaging should reveal exudative features
* Exudative AMD diagnosis established between 1 and 7 days before inclusion
* Monitored monthly
* Loading phase then bimonthly retreatment.
* Signed Informed Consent.
* Patient covered by the French Health Insurance

Exclusion Criteria

* Polypoidal choroidal vasculopathy
* Type 3 neovascularization
* Choroidal neovascularization attributable to causes other than AMD
* Macular hematoma
* Pigment epithelial detachment higher than 150µm
* Fibrosis \> 50% lesion on fundus color photography, fibroglial scar
* Media opacity annoying acquisition
* Retinal vascular occlusion
* Diabetic retinopathy
* Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
* Refractive error \>-6D
* Active intraocular inflammation in the study eye
* Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
* Patient taking part in an interventional study at the time of enrolment.
* Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
* Pregnant and lactating women
* Stroke and/or myocardial infarction 3 months before inclusion

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No