REPERM-OCT: The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tested patients Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography |
Device: OCT angiography
|
| Active Comparator: Control patients Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans |
Device: OCT B-scans
|
Outcome Measures
Primary Outcome Measures
- Visual acuity improvement or stabilization [Between the inclusion and 1 year of follow-up]
Proportion of patients with visual acuity improvement or stabilization
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patient ≥ 50 years old
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with exudative ARMD,
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treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata)
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Absence of atrophy of the central pigment epithelium
Exclusion Criteria
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Opposition to participate in this research
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Persons enjoying legal protection measure
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Lack of affiliation to social security and universal health coverage
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Pregnant or lactating
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Another cause of Choroidal neovascularization
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Unbalanced glaucoma
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Eye surgery less than 3 months on the studied eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondation Ophtalmologique A. de Rotchschild | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MMT_2015_42