Retinal Neovascularization Clinical Trial
— IVT-RNFLNCT number | NCT02876198 |
Other study ID # | MMT_2015_41 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | April 15, 2021 |
Verified date | August 2021 |
Source | Fondation Ophtalmologique Adolphe de Rothschild |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
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 |
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