NCT02868086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

August 11, 2016

Last Update Submit

January 2, 2026

Conditions

Age-related Macular Degeneration

Keywords

Age-related macular degenerationOptical coherence tomography angiography

Outcome Measures

Primary Outcomes (1)

  • Visual acuity improvement or stabilization

    Proportion of patients with visual acuity improvement or stabilization

    Between the inclusion and 1 year of follow-up

Study Arms (2)

Tested patients

EXPERIMENTAL

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

Device: OCT angiography

Control patients

ACTIVE COMPARATOR

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

Device: OCT B-scans

Interventions

OCT B-scansDEVICE
Control patients
OCT angiographyDEVICE
Tested patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

Related Publications (1)

  • 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.

    PMID: 35285308RESULT

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

October 21, 2016

Primary Completion

November 20, 2020

Study Completion

April 15, 2021

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

FR(1)