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

NCT ID: NCT02876198

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2021-04-15

Brief Summary

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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

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Conditions

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Retinal Neovascularization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients treated with anti-VEGF

Gonioscopy

Intervention Type DEVICE

Study of the trabecular structure by gonioscopy

Interventions

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Gonioscopy

Study of the trabecular structure by gonioscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Pole Vision du val d'Ouest

Lyon, , France

Site Status

Fondation Ophtalmologique A. de Rotchschild

Paris, , France

Site Status

Centre médical et chirurgical de la rétine

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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MMT_2015_41

Identifier Type: -

Identifier Source: org_study_id

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