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

NCT ID: NCT02868086

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-21
• Study Completion Date: 2021-04-15

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.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Tested patients

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

Group Type: EXPERIMENTAL

OCT angiography

Intervention Type: DEVICE

Control patients

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

Group Type: ACTIVE_COMPARATOR

OCT B-scans

Intervention Type: DEVICE

Interventions

OCT B-scans

Intervention Type: DEVICE

OCT angiography

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation Ophtalmologique A. de Rotchschild

Paris, , France

Countries

France

References

Sukkarieh G, Vasseur V, Lejoyeux R, Wolff B, Mauget-Faysse M. One-year outcome of neovascular age-related macular degeneration patients followed-up using different optical coherence tomography modalities. Eur J Ophthalmol. 2022 Nov;32(6):3503-3509. doi: 10.1177/11206721221088260. Epub 2022 Mar 14.

Reference Type: RESULT

PMID: 35285308 (View on PubMed)

Other Identifiers

MMT_2015_42

Identifier Type: -

Identifier Source: org_study_id