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

NCT02868086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-01-06

No results posted yet for this study

Summary

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

  • Age-related Macular Degeneration

Interventions

DEVICE

OCT B-scans

DEVICE

OCT angiography

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-21
Primary Completion
2020-11-20
Completion
2021-04-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868086 on ClinicalTrials.gov