Last updated: December 5, 2022
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Completed
Phase
3
Condition
Retina
Macular Degeneration
Myopic Macular Degeneration
Treatment
N/AClinical Study ID
NCT02157077
ARI2
2013-002869-19
Ages > 50 All Genders
Study Summary
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
Connect with a study center
Hôpital Pellegrin
Bordeaux, 33000
FranceSite Not Available
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
FranceSite Not Available
Hôpital général de Dijon
Dijon, 21033
FranceSite Not Available
Centre d'Ophtalmologie Rabelais
Lyon, 69003
FranceSite Not Available
Cabinet Alpes Rétine
Montbonnot-Saint-Martin, 38330
FranceSite Not Available
CHR Hôtel Dieu
Nantes, 44093
FranceSite Not Available
Centre d'explorations ophtalmologiques de l'odéon
Paris, 75006
FranceSite Not Available
Hôpital des Quinze-Vingts
Paris, 75012
FranceSite Not Available
Clinique Mathilde
Rouen, 76100
FranceSite Not Available
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