Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration (ARI2)

Centre Hospitalier Intercommunal Creteil

Status and phase

Completed

Phase 3

Conditions

Macular Degeneration

Retinal Degeneration

Wet Macular Degeneration

Eye Diseases

Retinal Diseases

Treatments

Drug: Aflibercept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02157077

2013-002869-19 (EudraCT Number)

ARI2

Details and patient eligibility

About

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.

Full description

The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.

Enrollment

90 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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 retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
Any history of macular hole of stage 3 and above in the study eye.
Uncontrolled glaucoma (defined as intraocular pressure ≥25 mmHg despite treatment with antiglaucoma medication) or prior laser treatment for glaucoma in the study eye.
Active intraocular inflammation or uveitis of scleritis or episcleritis in the study eye or ocular or periocular infection in either eye
Presence or history of scleromalacia in the study eye.
Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
Previous therapeutic radiation in the study eye.
History of corneal transplant or corneal dystrophy in the study eye.
Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of toxicity, or fundus photography.
Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 24 month study period.
Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
Any systemic treatment with an investigational agent except dietary supplements or vitamins in the past 6 months prior to Day 1 for any condition.
Any history of allergy to povidone iodine.
Contraindications as listed
Patient enrolled in another interventional research or not
Patient already included in the study for the treatment of one of his eye
Pregnant or nursing woman
Lack of effective contraception for women of childbearing age