Phase II study evaluating the efficacy of aflibercept for the treatment of idiopathic choroidal neovascularization in young subjects: the INTUITION study

• Conditions: idiopathic choroidal neovascularization; MedDRA version: 18.0Level: LLTClassification code 10060837Term: Choroidal neovascularizationSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-005081-19-FR
• Lead Sponsor: HOSPICES CIVILS DELYO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-17
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- patients between 18 and 50 years;
- Patient has given and signed free informed consent
- Patient affiliated to a social security or equivalent;
- Patient suffering from idiopathic choroidal neovascularization lesions with active subfoveal, or juxtafoveal primary location affecting the fovea, demonstrated by angiography (fluorescein and / or indocyanine green) and / or OTC;
- Patient willing and able to return to all clinical study visits and perform all procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant women;
- Male or female of childbearing age , sexually active, who do not want to commit to use a means of adequate contraception during the study;
- Patient protected under the terms of the law ( Code of Public Health ) ;
- Participation of the patient to another clinical trial ( study eye and / or eye not studied ) ;
- Patient suffering from non idiopathic choroidal neovascularizationnot , especially
- Patient with AMD ;
- Patient with high myopia defined by refraction = -6 diopters ;
- Other curative treatment of idiopathic choroidal neovascularization in the study eye within 3 months before the first intravitreal injection : anti -VEGF therapy, macular laser juxta- or extra- foveal , PDT , surgery, external radiotherapy, transpupillary thermotherapy ...
- History focal macular laser photocoagulation of subfoveal the study eye ;
- Presence of a subretinal hemorrhage reaching the center of the fovea , size of = 50 % of the surface of the lesion ;
- Subfoveal fibrosis or retinal atrophy of the study eye ;
- Tear of the retinal pigmented epithelium reaching the macula of the eye studied .
- History of intravitreal devices in the study eye ;
- History of autoimmune or idiopathic uveitis ;
- Diabetic retinopathy proved ;
- Intraocular pressure > 25 mmHg despite two treatments antiglaucoma eye drops ;
- Aphakia or absence of posterior capsule (other than Yag laser capsulotomy ) in the study eye ;
- Uncontrolled hypertension by appropriate treatment ;
- History of treatment or ongoing treatment with systemic anti -VEGF;
- Hypersensitivity to the active substance or to any of the excipients ; , known fluorescein, indocyanine green and anesthetic eye drops allergy
- Eye infection or active or suspected periocular ;
- Severe intraocular inflammation active ;
- Intraocular surgery within 28 days before the first intravitreal injection in the study eye ;
- Any eye disease or condition of the eye studied by the investigator might need an intraocular surgery within 12 months ;
- 12 months Follow-up impossible

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified