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

Fondation Ophtalmologique Adolphe de Rothschild3 sites in 1 country74 target enrollmentJuly 1, 2016

ConditionsRetinal Neovascularization

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Retinal Neovascularization
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Enrollment: 74
Locations: 3
Primary Endpoint: change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2016

End Date

April 15, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF

Time Frame: Change from baseline RNFL's thickness at Month 12

RNFL's thickness (in microns) measured with the Heildelberg glaucoma module of the spectral domain Optical Cohérence Tomographie (OCT Spectralis, Heidelberg engeening).