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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Completed
• CT.gov ID: NCT02876198
• Collaborator: (none)
• Enrollment: 74
• Locations: 3
• Actual Duration (Months): 57.5
• Patients Per Site: 24.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Neovascularization	Device: Gonioscopy

Study Design

• Study Type: Observational
• Actual Enrollment: 74 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Jan 30, 2021
• Actual Study Completion Date: Apr 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients treated with anti-VEGF	Device: Gonioscopy; Study of the trabecular structure by gonioscopy

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Pole Vision du val d'Ouest	Lyon		France
2	Fondation Ophtalmologique A. de Rotchschild	Paris		France	75019
3	Centre médical et chirurgical de la rétine	Strasbourg		France

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT02876198
• Other Study ID Numbers: MMT_2015_41
• First Posted: Aug 23, 2016
• Last Update Posted: Aug 3, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild: Retinal neovascularization; Anti-VEGF; Retinal Nerve Fiber Layer (RNFL)
• Additional relevant MeSH terms: Retinal Neovascularization; Neovascularization, Pathologic

Study Results

No Results Posted as of Aug 3, 2021