Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration (NCT02157077) | Clinical Trial Compass
CompletedPhase 3
Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration
France90 participantsStarted 2013-12
Plain-language summary
The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis.
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Men and women ≥ 50 years of age
* Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affect the fovea evidenced by Fluorescein Angiography in the study eye
* Patient having been treated for at least 12 months with Ranibizumab (≥ 8 injections)
* Patient with a PED \> 250 µm, defined by spectral domain optical coherent tomography (SD-OCT), measured at two consecutive visits before inclusion with any persisting sub retinal fluid at baseline
* Patient affiliated to a social security scheme
* Signed Informed Consent
Exclusion Criteria:
* Patient with subfoveal atrophy and/or atrophy with a diameter greater than 150µm in the subfoveal or juxtafoveal area
* Patient with a subfoveal fibrosis
* Subretinal hemorrhage that is either 50 percent or more of the total lesion area or 1 or more disc areas in size in the study eye.
* Scar, fibrosis or atrophy making up \> 50% of total lesion in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
* History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
* Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye or clinical evidence of diabetic…
What they're measuring
1
Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks