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

Primary Purpose

Inflammatory Choroidal Neovascularization

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Choroidal Neovascularization focused on measuring Aflibercept, inflammatory choroidal neovascularization, young patient

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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 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
  • Proved diabetic retinopathy
  • Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
  • Aphakia or lack of lens capsule (not removed by YAG (yttrium aluminium garnet) laser) in the studied eye
  • Arterial hypertension that is not controlled by an appropriate treatment and defined by one measure of systolic blood pressure > 180mmHG or 2 consecutive measures > 160mmHg, or by a diastolic blood pressure > 100mmHg
  • Antecedents of cerebrovascular disease or myocardial infarction during the last 6 months before inclusion (J1)
  • Antecedents of any pathology, metabolic disease, or any serious suspicion of disease during the clinical or laboratory exam that would contraindicate the use of the product, could affect the interpretation of the study results or lead to major risks of complication for the subject
  • Renal insufficiency requiring dialysis or renal transplantation
  • Previous (less than a year) or actual treatment with systemic administration of anti-VEGF therapy
  • Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanine green, anaesthetic eye drops
  • Active or suspected ocular or peri-ocular infection
  • Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
  • Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
  • Follow up not possible during 12 months

Sites / Locations

  • Hospices Civils de Lyon / Hopital de la Croix Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept

Arm Description

Intravitreal injection of aflibercept (EYLEA) / 2mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52
Number of injections per patient
Mean time between 2 injections
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 52
Mean change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Side-effects observed during the study
Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52

Full Information

First Posted
September 18, 2015
Last Updated
November 6, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02556229
Brief Title
Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory CNV in Young Patients (ALINEA).
Acronym
ALINEA
Official Title
Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory Choroidal Neovascularization (CNV) in Young Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Choroidal Neovascularization
Keywords
Aflibercept, inflammatory choroidal neovascularization, young patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Experimental
Arm Description
Intravitreal injection of aflibercept (EYLEA) / 2mg
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
BCVA is measured on the ETDRS scale at an initial distance of 4 meters
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
Time Frame
24 weeks
Title
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24
Time Frame
24 weeks
Title
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52
Time Frame
52 weeks
Title
Number of injections per patient
Time Frame
52 weeks
Title
Mean time between 2 injections
Time Frame
52 weeks
Title
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24
Time Frame
24 weeks
Title
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 52
Time Frame
52 weeks
Title
Mean change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Time Frame
52 weeks
Title
Side-effects observed during the study
Time Frame
52 weeks
Title
Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Proved diabetic retinopathy Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments Aphakia or lack of lens capsule (not removed by YAG (yttrium aluminium garnet) laser) in the studied eye Arterial hypertension that is not controlled by an appropriate treatment and defined by one measure of systolic blood pressure > 180mmHG or 2 consecutive measures > 160mmHg, or by a diastolic blood pressure > 100mmHg Antecedents of cerebrovascular disease or myocardial infarction during the last 6 months before inclusion (J1) Antecedents of any pathology, metabolic disease, or any serious suspicion of disease during the clinical or laboratory exam that would contraindicate the use of the product, could affect the interpretation of the study results or lead to major risks of complication for the subject Renal insufficiency requiring dialysis or renal transplantation Previous (less than a year) or actual treatment with systemic administration of anti-VEGF therapy Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanine green, anaesthetic eye drops Active or suspected ocular or peri-ocular infection Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion Follow up not possible during 12 months
Facility Information:
Facility Name
Hospices Civils de Lyon / Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

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

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