CompletedPhase 2

Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory CNV in Young Patients (ALINEA).

France20 participantsStarted 2016-06

Plain-language summary

Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed. InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need as many injections as in AMD. ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. The first injection is mandatory. The other ones are injected only in case of active InCNV.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion Criteria: * 18 \< Age \< 60 years old * Patient who give voluntary signed informed consent * Patient affiliated with the French universal health care system or similar * Patient with inflammatory CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis or Birdshot chorioretinopathy with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanine green) and/or SD-OCT in the studied eye * Patient willing, committed and able to return for all clinic visits and complete all study-related procedures Exclusion Criteria: * Pregnant women * Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study * Patient who is protected adults according to the terms of the law (French public health laws) * Involvement in another clinical trial (studied eye and/or the other eye) * Patient with non-inflammatory CNV, especially: * AMD * drusen associated with neovessel * High myopia defined as refraction ≥ - 6 diopters * Other curative treatment of inflammatory CNV in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ... * Medical history of retrofoveal focal macular laser photocoagulati…

What they're measuring

Mean change in best-corrected visual acuity (BCVA) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52

Timeframe: 52 weeks

Trial details

NCT IDNCT02556229

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09