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

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ClinicalTrials.gov Identifier: NCT02157077
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Eric Souied, Centre Hospitalier Intercommunal Creteil

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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 : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


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




Primary Outcome Measures :
  1. Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in central retinal thickness by SD OCT at 12 weeks [ Time Frame: Baseline and 12 weeks ]
  2. Change from Baseline in visual acuity at 12 weeks [ Time Frame: Baseline and 12 weeks ]
  3. Change from Baseline in volume of pigment epithelium detachment at 12 weeks [ Time Frame: Baseline and 12 weeks ]
  4. Association with genes involved in AMD history [ Time Frame: genetic testing will be performed when all the particpitants will be recruited ]
  5. Number of participants with adverse events from baseline to 32 weeks [ Time Frame: from baseline to 32 weeks ]
  6. Change from Baseline in pigment epithelium detachment height at 12 weeks [ Time Frame: Baseline and 12 weeks ]
  7. Change from baseline in central retinal thickness at 32 weeks [ Time Frame: baseline and 32 weeks ]
  8. Change from Baseline in pigment epithelium detachment height at 32 weeks [ Time Frame: Baseline and 32 weeks ]
  9. Change from Baseline in visual acuity at 32 weeks [ Time Frame: Baseline and 32 weeks ]
  10. Change from Baseline in volume of pigment epithelium detachment at 32 weeks [ Time Frame: Baseline and 32 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157077


Locations
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France
Hôpital Pellegrin
Bordeaux, France, 33000
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94010
Hôpital général de Dijon
Dijon, France, 21033
Centre d'Ophtalmologie Rabelais
Lyon, France, 69003
Cabinet Alpes Rétine
Montbonnot-Saint-Martin, France, 38330
CHR Hôtel Dieu
Nantes, France, 44093
Centre d'explorations ophtalmologiques de l'odéon
Paris, France, 75006
Hôpital des Quinze-Vingts
Paris, France, 75012
Clinique Mathilde
Rouen, France, 76100
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Bayer
Investigators
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Study Director: Eric Souied, MD Centre Hospitalier Intersommunal de Créteil

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Souied, Ophtalmologiste, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02157077     History of Changes
Other Study ID Numbers: CHIC-ARI2
2013-002869-19 ( EudraCT Number )
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016

Keywords provided by Eric Souied, Centre Hospitalier Intercommunal Creteil:
Eye diseases
Vision Impairment and Blindness
Eyes and Vision
Seniors
Neovascular Age-Related Macular Degeneration (AMD)
Retinal Disease

Additional relevant MeSH terms:
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Eye Diseases
Eye Diseases, Hereditary
Macular Degeneration
Retinal Diseases
Retinal Degeneration
Wet Macular Degeneration
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents