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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.
Full 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:
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 predominantly classic, minimally classic, or occult lesions with no classic component, all with subfoveal CNV secondary to AMD. All patients are pre-treated with intravitreal ranibizumab in a treat and extend regimen and failed to be extended to 6-weeks intervals without showing CNV activity.
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Exclusion criteria
Study design/interventions: 1-arm interventional investigator-initiated study with 2mg aflibercept intravitreally with up to 4-weekly treatment in a treat and extend regimen. The first treatment interval with aflibercept will be 4 weeks and corresponding to the treat and extend regimen 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. At every scheduled treat and extend visit (including baseline but excluding exit visit) an aflibercept injection is administered with a maximum of 6 injections during the study period.
Study visits: Baseline (4 weeks after last ranibizumab treatment), 4 weeks (28±2days), further visits according to treat and extend regimen (see above) at x weeks±2days with one week=7days, Exit visit (24 weeks±2days).
Study examinations/evaluations (both eyes):
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33 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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