Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF (IVT-RNFL)

The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.

Study Overview

• Status: Completed
• Conditions: Retinal Neovascularization
• Intervention / Treatment: Device: Gonioscopy

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Centre Pôle Vision du val d'Ouest
  • Paris, France, 75019
    • Fondation Ophtalmologique A. de Rotchschild
  • Strasbourg, France
    • Centre médical et chirurgical de la rétine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be recruited during a consultation in ophtalmology after prescription of an anti-VEGF treatment.

The study will not change the patient's usual care schedule. Only a different analysis of the images obtained by SD -OCT will be performed, and a gonioscopy will be carried out systematically the inclusion of patient and 12 months.

The data for the study will be collected at the inclusion visit and at the final visit of the study at 12 months.

Description

Inclusion Criteria:

• Age ≥18 years old
• Patients treated with anti-VEGF according to the French summary of product characteristics (SPC)
• Patients who have been informed of the trial and who are not opposed to participate in the study

Exclusion Criteria:

• Patients presenting a retinal condition, including the optic nerve
• Patients treated with anti-VEGF in both eyes
• Pregnant women
• Lack of affiliation to social security or universal health coverage

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with anti-VEGF	Device: Gonioscopy; Study of the trabecular structure by gonioscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF	RNFL's thickness (in microns) measured with the Heildelberg glaucoma module of the spectral domain Optical Cohérence Tomographie (OCT Spectralis, Heidelberg engeening).	Change from baseline RNFL's thickness at Month 12

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): January 30, 2021
• Study Completion (ACTUAL): April 15, 2021

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (ESTIMATE): August 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Anti-VEGF; Retinal neovascularization; Retinal Nerve Fiber Layer (RNFL)
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Metaplasia; Neovascularization, Pathologic; Retinal Neovascularization
• Other Study ID Numbers: MMT_2015_41