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

Retinal Neovascularization Clinical Trial

— IVT-RNFL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876198
• Other study ID #: MMT_2015_41
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: April 15, 2021

Study information

• Verified date: August 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 15, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Retinal Neovascularization

Intervention

Device:
• Gonioscopy
Study of the trabecular structure by gonioscopy

Locations

Country	Name	City	State
France	Centre Pole Vision du val d'Ouest	Lyon
France	Fondation Ophtalmologique A. de Rotchschild	Paris
France	Centre médical et chirurgical de la rétine	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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