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

NCT ID: NCT03435926

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-13

Study Completion Date

2021-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Choroidal Neovascularization, Visual Field, Visual Acuity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Limoges, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

NATHALIE LABROUSSE, Dr

Role: CONTACT

+33681529217

PIERRE-YVES ROBERT, Pr

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

NATHALIE LABROUSSE, Dr

Role: primary

+33681529217

PIERRE-YVES ROBERT, Pr

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I16021 (CORFI)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Retinal Investigation Using Optos OCT Device
NCT06846151 NOT_YET_RECRUITING NA
Dual Wavelength OCT
NCT03843840 COMPLETED