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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02876198
Acronym
IVT-RNFL
Enrollment
74
Registered
2016-08-23
Start date
2016-07-01
Completion date
2021-04-15
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Neovascularization

Keywords

Retinal neovascularization, Anti-VEGF, Retinal Nerve Fiber Layer (RNFL)

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.

Interventions

Study of the trabecular structure by gonioscopy

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026