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Trial record 25 of 34 for:    myopic macular degeneration

Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients (INTUITION)

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ClinicalTrials.gov Identifier: NCT02257502
Recruitment Status : Active, not recruiting
First Posted : October 6, 2014
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50 years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown. This is a rare and severe disease, which can lead to blindness.

ICNV 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 Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not need as many injections as in AMD.

INTUITION 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 ICNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE) regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in case of CNV activity).


Condition or disease Intervention/treatment Phase
Idiopathic Choroidal Neovascularization Drug: aflibercept Phase 2

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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 Iodiopathic Choroidal Neovascularization in Young Patients
Actual Study Start Date : July 6, 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aflibercept
intravitreal injection of aflibercept (EYLEA)
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 with a TAE regimen until 20 weeks (3 mandatory injections at inclusion, week 8 and 20 with reinjection at week 4, 12 and 16 only in case of CNV activity). Then, a PRN regimen is considered until 52 weeks (reinjection in case of CNV activity). Therefore, each patient receives between 3 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. Mean number of injections per patient during the TAE regimen (until week 20) [ Time Frame: 20 weeks ]
  5. Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20) [ Time Frame: 32 weeks ]
  6. Mean total number of injections per patient during the study [ Time Frame: 52 weeks ]
  7. 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 ]
  8. Mean change in CRT in micrometers measured with SD-OCT from baseline to week 52 [ Time Frame: 52 weeks ]
  9. Mean change in neovascular lesion size and morphology measured with fluorescein and/or indocyanin green angiography from baseline to week 52 [ Time Frame: 52 weeks ]
  10. Side-effects observed during the study [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 < Age < 50 years old
  • Patient who give voluntary signed informed consent
  • Patient affiliated with the French universal health care system or similar
  • Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin 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-ICNV, especially:

    • AMD
    • High myopia defined as refraction ≥ - 6 diopters
  • Other curative treatment of ICNV 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 haemorrhage reaching the fovea centre, 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 laser) in the studied eye
  • Arterial hypertension that is not controlled by an appropriate treatment
  • Previous 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, indocyanin green, anaesthetic eye drops
  • Active or suspected ocular or peri-ocular infection
  • Serious active intra-ocular inflammation in the studied eye
  • 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): NCT02257502


Locations
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France
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Laurent KODJIKIAN Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02257502     History of Changes
Other Study ID Numbers: 2013.839
2013-005081-19 ( EudraCT Number )
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Keywords provided by Hospices Civils de Lyon:
aflibercept
iodiopathic choroidal neovascularization
young patient

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