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

NCT02257502 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Laurent KODJIKIAN · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-06
Primary Completion
2019-07-11
Completion
2019-07-11

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257502 on ClinicalTrials.gov