Intravitreal Aflibercept in Neovascular AMD With Limited Response to Ranibizumab
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Title: Intravitreal aflibercept (VEGF Trap-Eye) in neovascular age-related macular
degeneration with limited response to ranibizumab
Purpose: The purpose of this investigator initiated study is to identify the duration of
treatment effects of intravitreal aflibercept on sub- and intraretinal fluid and best
corrected visual acuity (BCVA) in choroidal neovascularizations (CNV) due to age-related
macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment
interval failed to be extended to 6 weeks intervals in a treat and extend regimen.
Objectives: The primary objective is to evaluate the mean maximum recurrence-free treatment
interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid (for
explanation see section Objectives). The individual maximum recurrence-free treatment
interval (in weeks) at 24 weeks is defined as the maximum extension interval which is reached
during the study follow-up period without showing any CNV activity (any intra-or subretinal
fluid at OCT or new retinal hemorrhage). This measure reflects the duration of aflibercept
effect in these lesions with limited response to ranibizumab. Key secondary Outcome Measures
are mean changes in BCVA score at 24 weeks from baseline (Δ BCVAscore), mean changes in CRT
(µm) at 24 weeks from baseline (Δ CRT), mean number of treatments needed during the 24 weeks
study follow-up, number of participants with adverse events and serious adverse events (for
further outcome measures see section Objectives).
Population: This outpatient study population will consist of a representative group of 33
male and female patients ≥ 50 years of age. The study population will include patients with
subfoveal CNV secondary to AMD and being pre-treated with intravitreal ranibizumab in a treat
and extend regimen and failed to be extended to 6-weeks intervals without showing CNV
activity (for further information see section Criteria).
Interventions: 1-arm interventional study with 2mg aflibercept intravitreally up to 4-weekly.
The first treatment interval with aflibercept will be 4 weeks and corresponding to the treat
and extend regime intervals will be increased in 2-weeks-steps as long as no CNV activity
(any intra-or subretinal fluid at OCT or new retinal hemorrhage) occurs. In case of occuring
CNV activity the interval is shortened by 4 weeks with a minimum treatment interval of 4
weeks.