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

Primary Purpose

Idiopathic 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 Idiopathic Choroidal Neovascularization focused on measuring aflibercept, iodiopathic choroidal neovascularization, young patient

Eligibility Criteria

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

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

Sites / Locations

  • Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aflibercept

Arm Description

intravitreal injection of aflibercept (EYLEA)

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
Mean number of injections per patient during the TAE regimen (until week 20)
Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20)
Mean total number of injections per patient during the study
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 CRT in micrometers measured with SD-OCT from baseline to week 52
Mean change in neovascular lesion size and morphology measured with fluorescein and/or indocyanin green angiography from baseline to week 52
Side-effects observed during the study

Full Information

First Posted
October 2, 2014
Last Updated
July 22, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02257502
Brief Title
Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients
Acronym
INTUITION
Official Title
Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Iodiopathic Choroidal Neovascularization in Young Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2015 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Choroidal Neovascularization
Keywords
aflibercept, iodiopathic 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)
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 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 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
Mean number of injections per patient during the TAE regimen (until week 20)
Time Frame
20 weeks
Title
Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20)
Time Frame
32 weeks
Title
Mean total number of injections per patient during the study
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 CRT in micrometers measured with SD-OCT from baseline to week 52
Time Frame
52 weeks
Title
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
Title
Side-effects observed during the study
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent KODJIKIAN
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital 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 NVCI in Young Patients

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