Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration

Last updated: December 5, 2022
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Completed

Phase

3

Condition

Retina

Macular Degeneration

Myopic Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT02157077
ARI2
2013-002869-19
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women ≥ 50 years of age
  • Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMDincluding juxtafoveal lesions that affect the fovea evidenced by FluoresceinAngiography 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 subretinal fluid at baseline
  • Patient affiliated to a social security scheme
  • Signed Informed Consent

Exclusion

Exclusion Criteria:

  • Patient with subfoveal atrophy and/or atrophy with a diameter greater than 150µm inthe subfoveal or juxtafoveal area
  • Patient with a subfoveal fibrosis
  • Subretinal hemorrhage that is either 50 percent or more of the total lesion area or 1or 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 studyeye.
  • 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 ormore), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, ormultifocal 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 withantiglaucoma medication) or prior laser treatment for glaucoma in the study eye.
  • Active intraocular inflammation or uveitis of scleritis or episcleritis in the studyeye 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 aresult 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 mightinterfere with visual acuity, assessment of toxicity, or fundus photography.
  • Any concurrent intraocular condition in the study eye (e.g. cataract) that, in theopinion of the investigator, could require either medical or surgical interventionduring the 24 month study period.
  • Any concurrent ocular condition in the study eye which, in the opinion of theinvestigator, could either increase the risk to the subject beyond what is to beexpected from standard procedures of intraocular injection, or which otherwise mayinterfere with the injection procedure or with evaluation of efficacy or safety.
  • Any systemic treatment with an investigational agent except dietary supplements orvitamins 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

Study Design

Total Participants: 90
Study Start date:
December 01, 2013
Estimated Completion Date:
December 31, 2015

Study Description

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

Connect with a study center

  • Hôpital Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010
    France

    Site Not Available

  • Hôpital général de Dijon

    Dijon, 21033
    France

    Site Not Available

  • Centre d'Ophtalmologie Rabelais

    Lyon, 69003
    France

    Site Not Available

  • Cabinet Alpes Rétine

    Montbonnot-Saint-Martin, 38330
    France

    Site Not Available

  • CHR Hôtel Dieu

    Nantes, 44093
    France

    Site Not Available

  • Centre d'explorations ophtalmologiques de l'odéon

    Paris, 75006
    France

    Site Not Available

  • Hôpital des Quinze-Vingts

    Paris, 75012
    France

    Site Not Available

  • Clinique Mathilde

    Rouen, 76100
    France

    Site Not Available

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