ARI2: Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Completed

CT.gov ID

NCT02157077

Collaborator

Bayer (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases	Drug: Aflibercept	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aflibercept Patients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26	Drug: Aflibercept Intravitreal Injection Other Names: Eylea BAY86-5321

Arm

Intervention/Treatment

Experimental: Aflibercept

Patients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26

Drug: Aflibercept

Intravitreal Injection

Other Names:

Eylea

BAY86-5321

Outcome Measures

Primary Outcome Measures

Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks [Baseline and 12 weeks]

Secondary Outcome Measures

Change from baseline in central retinal thickness by SD OCT at 12 weeks [Baseline and 12 weeks]
Change from Baseline in visual acuity at 12 weeks [Baseline and 12 weeks]
Change from Baseline in volume of pigment epithelium detachment at 12 weeks [Baseline and 12 weeks]
Association with genes involved in AMD history [genetic testing will be performed when all the particpitants will be recruited]
Number of participants with adverse events from baseline to 32 weeks [from baseline to 32 weeks]
Change from Baseline in pigment epithelium detachment height at 12 weeks [Baseline and 12 weeks]
Change from baseline in central retinal thickness at 32 weeks [baseline and 32 weeks]
Change from Baseline in pigment epithelium detachment height at 32 weeks [Baseline and 32 weeks]
Change from Baseline in visual acuity at 32 weeks [Baseline and 32 weeks]
Change from Baseline in volume of pigment epithelium detachment at 32 weeks [Baseline and 32 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Pellegrin	Bordeaux	France	33000
2	Centre Hospitalier Intercommunal de Créteil	Créteil	France	94010
3	Hôpital général de Dijon	Dijon	France	21033
4	Centre d'Ophtalmologie Rabelais	Lyon	France	69003
5	Cabinet Alpes Rétine	Montbonnot-Saint-Martin	France	38330
6	CHR Hôtel Dieu	Nantes	France	44093
7	Centre d'explorations ophtalmologiques de l'odéon	Paris	France	75006
8	Hôpital des Quinze-Vingts	Paris	France	75012
9	Clinique Mathilde	Rouen	France	76100