Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration

Macular Degeneration Clinical Trial

— ARI2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157077
• Other study ID #: ARI2
• Secondary ID: 2013-002869-19
• Status: Completed
• Phase: Phase 3
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Macular Degeneration
• Retinal Degeneration
• Retinal Diseases
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept
Intravitreal Injection

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux
France	Centre Hospitalier Intercommunal de Créteil	Créteil
France	Hôpital général de Dijon	Dijon
France	Centre d'Ophtalmologie Rabelais	Lyon
France	Cabinet Alpes Rétine	Montbonnot-Saint-Martin
France	CHR Hôtel Dieu	Nantes
France	Centre d'explorations ophtalmologiques de l'odéon	Paris
France	Hôpital des Quinze-Vingts	Paris
France	Clinique Mathilde	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks		Baseline and 12 weeks
Secondary	Change from baseline in central retinal thickness by SD OCT at 12 weeks		Baseline and 12 weeks
Secondary	Change from Baseline in visual acuity at 12 weeks		Baseline and 12 weeks
Secondary	Change from Baseline in volume of pigment epithelium detachment at 12 weeks		Baseline and 12 weeks
Secondary	Association with genes involved in AMD history		genetic testing will be performed when all the particpitants will be recruited
Secondary	Number of participants with adverse events from baseline to 32 weeks		from baseline to 32 weeks
Secondary	Change from Baseline in pigment epithelium detachment height at 12 weeks		Baseline and 12 weeks
Secondary	Change from baseline in central retinal thickness at 32 weeks		baseline and 32 weeks
Secondary	Change from Baseline in pigment epithelium detachment height at 32 weeks		Baseline and 32 weeks
Secondary	Change from Baseline in visual acuity at 32 weeks		Baseline and 32 weeks
Secondary	Change from Baseline in volume of pigment epithelium detachment at 32 weeks		Baseline and 32 weeks