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

Completed

• Conditions: Retinal Neovascularization
• Interventions: Device: Gonioscopy

• Registration Number: NCT02876198
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-23
• Primary Completion: 2021-01-30
• Study Completion: 2021-04-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with anti-VEGF	Gonioscopy	-

Primary Outcome Measures

Name	Time	Method
change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF	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).

Trial Locations

Locations (3)

Centre médical et chirurgical de la rétine; 🇫🇷 Strasbourg, France

Centre Pole Vision du val d'Ouest; 🇫🇷 Lyon, France

Fondation Ophtalmologique A. de Rotchschild; 🇫🇷 Paris, France