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

• Conditions: Choroidal Neovascularization, Visual Field, Visual Acuity

• Registration Number: NCT03435926
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study Start: 2018-02-13
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Status Verified: 2018-09
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23
• Primary Completion: 2021-02-13
• Study Completion: 2021-02-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fixation stability measured by microperimetry and exudative signs on OCT	2 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Limoges, France