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

Conditions

• Inflammatory Choroidal Neovascularization

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Aflibercept — DRUG
  The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated at inclusion (mandatory injection) with reinjection every 4 weeks only in case of CNV activity (PRN regimen) until 52 weeks.Therefore, each patient receives between 1 and 13 injections in the whole study.

Study Details

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.

Key Dates

Start date

Jun 30, 2016

Status verified

Aug 2025

Primary completion

Sep 30, 2019

Completion

Sep 30, 2019

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Aflibercept
  Intravitreal injection of aflibercept (EYLEA) / 2mg

Primary Outcome Measure

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 [ Time Frame: 52 weeks ]