Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 34 for:    myopic macular degeneration

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02556229
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Inflammatory Choroidal Neovascularization Drug: Aflibercept Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory Choroidal Neovascularization (CNV) in Young Patients.
Actual Study Start Date : June 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aflibercept
Intravitreal injection of aflibercept (EYLEA) / 2mg
Drug: Aflibercept
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 Measures :
  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 [ Time Frame: 52 weeks ]
    BCVA is measured on the ETDRS scale at an initial distance of 4 meters


Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24 [ Time Frame: 24 weeks ]
  3. Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52 [ Time Frame: 52 weeks ]
  4. Number of injections per patient [ Time Frame: 52 weeks ]
  5. Mean time between 2 injections [ Time Frame: 52 weeks ]
  6. 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 ]
  7. 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 ]
  8. Mean change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52 [ Time Frame: 52 weeks ]
  9. Side-effects observed during the study [ Time Frame: 52 weeks ]
  10. Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52 [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556229


Locations
Layout table for location information
France
Hospices Civils de Lyon / Hopital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02556229     History of Changes
Other Study ID Numbers: 69HCL14_0201
2014-003695-23 ( EudraCT Number )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Keywords provided by Hospices Civils de Lyon:
Aflibercept
inflammatory choroidal neovascularization
young patient

Additional relevant MeSH terms:
Layout table for MeSH terms
Neovascularization, Pathologic
Choroidal Neovascularization
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases