Clinical trial NCT02157077: Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration
Official title: A Phase III b, Multicenter Study of the Efficacy and Safety of Aflibercept Switch in Patients With Exudative AMD With Detachment of the Retinal Pigment Epithelium and Previously Treated With Ranibizumab Intravitreal Injection. (ARI2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Keywords: Eye diseases
Vision Impairment and Blindness
Eyes and Vision
Seniors
Neovascular Age-Related Macular Degeneration (AMD)
Retinal Disease
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in central retinal thickness by SD OCT at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in visual acuity at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in volume of pigment epithelium detachment at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Association with genes involved in AMD history
timeFrame: genetic testing will be performed when all the particpitants will be recruited
measure: Number of participants with adverse events from baseline to 32 weeks
timeFrame: from baseline to 32 weeks
measure: Change from Baseline in pigment epithelium detachment height at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in central retinal thickness at 32 weeks
timeFrame: baseline and 32 weeks
measure: Change from Baseline in pigment epithelium detachment height at 32 weeks
timeFrame: Baseline and 32 weeks
measure: Change from Baseline in visual acuity at 32 weeks
timeFrame: Baseline and 32 weeks
measure: Change from Baseline in volume of pigment epithelium detachment at 32 weeks
timeFrame: Baseline and 32 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Dijon
country: France
facility: Hôpital général de Dijon
city: Lyon
country: France
facility: Centre d'Ophtalmologie Rabelais
city: Montbonnot-Saint-Martin
country: France
facility: Cabinet Alpes Rétine
city: Nantes
country: France
facility: CHR Hôtel Dieu
city: Paris
country: France
facility: Centre d'explorations ophtalmologiques de l'odéon
city: Paris
country: France
facility: Hôpital des Quinze-Vingts
city: Rouen
country: France
facility: Clinique Mathilde
Study officials:
affiliation: Centre Hospitalier Intersommunal de Créteil
name: Eric Souied, MD
role: STUDY_DIRECTOR
References:
citation: Mouallem-Beziere A, Blanco-Garavito R, Richard F, Miere A, Jung C, Rozet JM, Souied EH. GENETICS OF LARGE PIGMENT EPITHELIAL DETACHMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Apr;40(4):663-671. doi: 10.1097/IAE.0000000000002454.