Age-related Macular Degeneration
Conditions
Keywords
Age-related macular degeneration, Optical coherence tomography angiography
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.
Interventions
DEVICEOCT B-scans
DEVICEOCT angiography
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity improvement or stabilization | Between the inclusion and 1 year of follow-up | Proportion of patients with visual acuity improvement or stabilization |
Countries
France
Outcome results
None listed