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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Age-related Macular Degeneration

Treatments: Device: OCT angiography; Device: OCT B-scans

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02868086

MMT_2015_42

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

Tested patients

Experimental group

Description:

Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography

Treatment:

Device: OCT angiography

Control patients

Active Comparator group

Description:

Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans

Treatment:

Device: OCT B-scans