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

NCT02556229 | Completed Phase 2 DMC

• 2 other identifiers: 69HCL14_02012014-003695-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Choroidal Neovascularization

Keywords

Aflibercept; inflammatory choroidal neovascularization; young patient

Outcome Measures

Primary Outcomes (1)

• 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

  BCVA is measured on the ETDRS scale at an initial distance of 4 meters

  52 weeks

Secondary Outcomes (10)

• Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24

  24 weeks

• Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24

  24 weeks

• Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52

  52 weeks

• Number of injections per patient

  52 weeks

• Mean time between 2 injections

  52 weeks

Study Arms (1)

Aflibercept

EXPERIMENTAL

Intravitreal injection of aflibercept (EYLEA) / 2mg

Drug: Aflibercept

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.

Aflibercept

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< 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

You may not qualify if:

• 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 photocoagulation in the studied eye
• Subretinal hemorrhage reaching the fovea center or with a size \> 50% of the lesion area
• Fibrosis or retrofoveal retinal atrophy in the studied eye
• Retinal pigment epithelial tear reaching the macula in the studied eye
• Medical history of intravitreal medical device in the studied eye
• Medical history of auto-immune or idiopathic uveitis

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon / Hopital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Kodjikian L, Abukhashabah A, Fardeau C, Tadayoni R, Brezin A, Dumas S, Weber M, Bernard L, Loria O, Decullier E, Huot L, Mathis T. Efficacy and safety of Aflibercept for the treatment of inflammatory choroidal neovascularization: The ALINEA study. Acta Ophthalmol. 2023 Feb;101(1):e43-e49. doi: 10.1111/aos.15214. Epub 2022 Jul 13.

  PMID: 35822428 RESULT

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: June 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)