OCT and Microperimetry in Patients With Active Neovascular ARMD (CORFI) (CORFI)

Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF

ARMD is the main cause of visual disability after 50 years old in France. Patients with active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular OCT but also on angiography when necessary).

The aim of this study is to evaluate the link between active neovascularization found on OCT and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.

Quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up for each patient. The mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered.

In case no link will be found, for instance bad fixation quality without exudative signs on OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.

Study Overview

• Status: Unknown
• Conditions: Choroidal Neovascularization, Visual Field, Visual Acuity

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: NATHALIE LABROUSSE, Dr; Phone Number: +33681529217; Email: nathalie-isa.labrousse@orange.fr
• Study Contact Backup: Name: PIERRE-YVES ROBERT, Pr; Email: pierre-yves.robert@unilim.fr

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • University Hospital
    • Contact: NATHALIE LABROUSSE, Dr; Phone Number: +33681529217; Email: nathalie-isa.labrousse@orange.fr
    • Contact: PIERRE-YVES ROBERT, Pr; Email: pierre-yves.robert@unilim.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with active neovascular ARMD treated with antiVEGF

Description

Inclusion Criteria:

• patients > 50 years old,
• With neovascular ARMD
• who need an induction treatment (de novo patients or patients who had their last intravitreal injection of antiVEGF more than 6 months ago)

Exclusion Criteria:

• Other maculopathies
• Severe glaucoma with central visual field defect
• Diabetic patients
• Corneal, lens or vitreous opacities interfering in OCT analysis
• Attention or comprehension deficit

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fixation stability measured by microperimetry and exudative signs on OCT	quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up. The fixation stability is classified as follows: Stable if more than 75% of the fixation points are contained inside the circle of 2 degrees of diameter; Relatively unstable if more than 75% of the fixation points are contained within the circle of 4 degrees of diameter and less than 75% contained within that of 2 degrees of diameter; Unstable if less than 75% of the fixation points are contained within the circle of 4 degrees of diameter	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bivariate Contour Ellipse Area (BCEA) value	BCEA will be gathered at each consultation over the two-years follow-up	2 years
mean central retinal sensitivity	mean central retinal sensitivity will be gathered at each consultation over the two-years follow-up	2 years
Best Corrected Visual Acuity (BCVA)	BCVA will be gathered at each consultation over the two-years follow-up	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Anticipated): February 13, 2021
• Study Completion (Anticipated): February 13, 2021

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic
• Other Study ID Numbers: I16021 (CORFI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No