Intravitreal Aflibercept (VEGF Trap-Eye) in Neovascular Age-related Macular Degeneration With Limited Response to Ranibizumab
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Primary Endpoint
- mean maximum recurrence-free treatment interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid
Study Overview
Brief 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.
Detailed Description
Title of study: Intravitreal aflibercept (VEGF Trap-Eye) in neovascular age-related macular degeneration with limited response to ranibizumab
Study purpose: The purpose of this investigator initiated study is to identify the duration of treatment effects of intravitreal aflibercept (VEGF Trap-Eye) 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 intravitreal aflibercept treatment in an OCT- and fundus examination- guided treat and extend regimen within a 24 weeks study period. 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.
Secondary Objectives are:
- mean changes in BCVA score at 24 weeks compared to baseline (Δ BCVAscore=BCVAscore 24 weeks - BCVAscore Baseline)
- mean changes in CRT (central retinal thickness; in µm) at 24 weeks compared to baseline (Δ CRT=CRT 24 weeks - CRT Baseline)
- percentage of patients with a maximum recurrence-free treatment interval of more than 4 weeks at 24 weeks
- mean number of treatments needed during the 24 weeks study follow-up
- percentage of lesions showing incidence of fluorescein leakage at baseline and 24 weeks.
- mean change in total lesion area at 24 weeks compared to baseline (ΔTotalArea=TotalArea 24weeks - TotalArea Baseline)
- mean change in area of leakage from CNV at 24 weeks compared to baseline (ΔLeakageArea=LeakageArea 24weeks - LeakageArea Baseline)
- change of quality of life scores (VFQ-25, EQ 5D) from baseline to 24 weeks.
- number of participants with adverse events (not fullfilling the criteria of serious adverse events) as a measure of safety and tolerability of up to 4weekly dosing of aflibercept in CNV due to AMD
- number of participants with serious adverse events as a measure of safety and tolerability of up to 4weekly dosing of aflibercept in CNV due to AMD
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
aflibercept 2mg
Aflibercept 2mg (Eylea) is intravitreally applied. 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.
Intervention: aflibercept 2mg (Drug)
Outcomes
Primary Outcomes
mean maximum recurrence-free treatment interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid
Time Frame: 24 weeks
All eligible patients have to show a maximum treatment interval with ranibizumab (pre-study period) of 4 weeks (failed to be extended to 6 weeks, see Inclusion criteria), meaning that the mean maximum treatment interval at baseline is 4 weeks. During the study the treatment intervals with aflibercept will be increased in 2-weeks steps corresponding to the treat and extend regime (see Study design). 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.
Secondary Outcomes
- mean changes in BCVA score at 24 weeks compared to baseline (Δ BCVAscore=BCVAscore 24 weeks - BCVAscore Baseline)(24 weeks)
- mean changes in CRT (central retinal thickness; in µm) at 24 weeks compared to baseline (Δ CRT=CRT 24 weeks - CRT Baseline)(24 weeks)
- number of participants with serious adverse events as a measure of safety and tolerability of up to 4weekly dosing of aflibercept in CNV due to AMD(24 weeks)
- percentage of patients with a maximum recurrence-free treatment interval of more than 4 weeks at 24 weeks(24 weeks)
- mean number of treatments needed during the 24 weeks study follow-up(24 weeks)
- percentage of lesions showing incidence of fluorescein leakage at baseline and 24 weeks.(24 weeks)
- mean change in total lesion area at 24 weeks compared to baseline (ΔTotalArea=TotalArea 24weeks - TotalArea Baseline)(24 weeks)
- mean change in area of leakage from CNV at 24 weeks compared to baseline (ΔLeakageArea=LeakageArea 24weeks - LeakageArea Baseline)(24 weeks)
- change of quality of life scores (VFQ-25, EQ 5D) from baseline to 24 weeks.(24 weeks)
- number of participants with adverse events (not fullfilling the criteria of serious adverse events) as a measure of safety and tolerability of up to 4weekly dosing of aflibercept in CNV due to AMD(24 weeks)
Investigators
Dr. med. Katja Hatz
Prof.
Vista Klinik