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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02257502

Collaborator

(none)

Enrollment

Location

Arm

48.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Choroidal Neovascularization	Drug: aflibercept	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

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 :

Jul 6, 2015

Actual Primary Completion Date :

Jul 11, 2019

Actual Study Completion Date :

Jul 11, 2019

Arms and Interventions

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.

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.

Outcome Measures

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 [52 weeks]
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 [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]
Mean number of injections per patient during the TAE regimen (until week 20) [20 weeks]
Mean time to reinjection after TAE regimen (i.e. after the 3rd mandatory injection at week 20) [32 weeks]
Mean total number of injections per patient during the study [52 weeks]
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24 [24 weeks]
Mean change in CRT in micrometers measured with SD-OCT from baseline to week 52 [52 weeks]
Mean change in neovascular lesion size and morphology measured with fluorescein and/or indocyanin green angiography from baseline to week 52 [52 weeks]
Side-effects observed during the study [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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