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

Age-related Macular Degeneration Clinical Trial

— REPERM-OCT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868086
• Other study ID #: MMT_2015_42
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Est. completion date: April 15, 2021

Study information

• Verified date: May 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 15, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• OCT B-scans

• OCT angiography

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rotchschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity improvement or stabilization	Proportion of patients with visual acuity improvement or stabilization	Between the inclusion and 1 year of follow-up