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

Not Applicable

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Device: OCT angiography; Device: OCT B-scans

• Registration Number: NCT02868086
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Study Start: 2016-10-21
• Primary Completion: 2020-11-20
• Study Completion: 2021-04-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tested patients	OCT angiography	Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography
Control patients	OCT B-scans	Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans

Primary Outcome Measures

Name	Time	Method
Visual acuity improvement or stabilization	Between the inclusion and 1 year of follow-up	Proportion of patients with visual acuity improvement or stabilization

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rotchschild; 🇫🇷 Paris, France