The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)

Study Overview
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Brief Summary
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The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The PRN surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an arterialization or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Device: OCT B-scans
* Device: OCT angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient ≥ 50 years old with exudative ARMD, treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata) Absence of atrophy of the central pigment epithelium Exclusion Criteria Opposition to participate in this research Persons enjoying legal protection measure Lack of affiliation to social security and universal health coverage Pregnant or lactating Another cause of Choroidal neovascularization Unbalanced glaucoma Eye surgery less than 3 months on the studied eye

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tested patients<br>Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography | Device: OCT angiography<br> <br> |
| Active Comparator: Control patients<br>Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans | Device: OCT B-scans<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity improvement or stabilization | Proportion of patients with visual acuity improvement or stabilization | Between the inclusion and 1 year of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, Optical coherence tomography angiography