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

NCT02876198 | Completed

• 1 other identifier: MMT_2015_41
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Retinal Neovascularization

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients treated with anti-VEGF

Device: Gonioscopy

Interventions

Gonioscopy DEVICE

Study of the trabecular structure by gonioscopy

Patients treated with anti-VEGF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited during a consultation in ophtalmology after prescription of an anti-VEGF treatment. The study will not change the patient's usual care schedule. Only a different analysis of the images obtained by SD -OCT will be performed, and a gonioscopy will be carried out systematically the inclusion of patient and 12 months. The data for the study will be collected at the inclusion visit and at the final visit of the study at 12 months.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (3)

Centre Pole Vision du val d'Ouest

Lyon, France

Location

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

Centre médical et chirurgical de la rétine

Strasbourg, France

Location

MeSH Terms

Conditions

Retinal Neovascularization

Interventions

Gonioscopy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 23, 2016
• Study Start: July 1, 2016
• Primary Completion: January 30, 2021
• Study Completion: April 15, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

FR (3)