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

NCT02257502 | Completed Phase 2

• 2 other identifiers: 2013.8392013-005081-19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Idiopathic Choroidal Neovascularization

Keywords

aflibercept; iodiopathic choroidal neovascularization; young patient

Outcome Measures

Primary Outcomes (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

  BCVA is measured on the ETDRS scale at an initial distance of 4 meters

  52 weeks

Secondary Outcomes (10)

• 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

Study Arms (1)

aflibercept

EXPERIMENTAL

intravitreal injection of aflibercept (EYLEA)

Drug: aflibercept

Interventions

aflibercept DRUG

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.

aflibercept

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Kodjikian L, Tadayoni R, Souied EH, Baillif S, Milazzo S, Dumas S, Uzzan J, Bernard L, Decullier E, Huot L, Mathis T. EFFICACY AND SAFETY OF AFLIBERCEPT FOR THE TREATMENT OF IDIOPATHIC CHOROIDAL NEOVASCULARIZATION IN YOUNG PATIENTS: The INTUITION Study. Retina. 2022 Feb 1;42(2):290-297. doi: 10.1097/IAE.0000000000003310.

  PMID: 34620799 RESULT

MeSH Terms

Interventions

aflibercept

Study Officials

• Laurent KODJIKIAN

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: July 6, 2015
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)