Ziv-aflibercept Efficacy in Better Regulating AMD

Study Overview
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Brief Summary
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This is a randomized, open-label, interventional, controlled study to determine the effects of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control anti-vascular endothelial growth factor (anti-VEGF) injections (bevacizumab, ranibizumab, or aflibercept).

Official Title
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An Active-treatment Study of the Efficacy of Ziv-aflibercept in Patients With Neovascular Age-Related Macular Degeneration

Conditions
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Wet Macular Degeneration, Wet Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are age 50-99 Have neovascular Age-related Macular Degeneration (AMD) with an eye undergoing maintenance treatment with one or more of the following anti-VEGF drugs: bevacizumab, ranibizumab, or aflibercept. Have an eye undergoing treatment that is of low visual potential (20/200 Snellen equivalent or worse) and the contralateral eye must have better visual potential. Are willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments. Have received an intravitreal injection of one of the drugs listed above within 120 days of Day 1 of the trial. Both males and females will be enrolled. Exclusion Criteria: Active intraocular inflammation or infection History of vitreous hemorrhage within three months prior to Day 1 of the study Uncontrolled ocular hypertension or glaucoma in the study eye (defined as Intraocular Pressure (IOP) >25 mm Hg or a Cup to Disc ratio > 0.8 despite treatment with anti-glaucoma medication) or any such condition which the investigator feels may warrant a glaucoma filtering surgery during the study History of stroke within the last three months prior to Day 1 of the study History of myocardial infarction within the last three months prior to Day 1 of the study Undergone intraocular surgery or laser treatments within the last three months, Significant Epiretinal Membrane (ERM) or Vitreomacular Traction (VMT) causing distortion of macular anatomy No use of ocular corticosteroids within the last six months and no use of systemic corticosteroids at a dose of >10 mg/day Not have active malignancies within the last 12 months except appropriately treated carcinoma in situ of the cervix, melanoma, and prostate cancers treated with a curative intent Inability to comply with study or follow-up procedures Women who may become pregnant or lactating or intend to become pregnant during the study Women who are of childbearing potential, including women who have had tubal ligation, must have a blood test within 21 days prior to Day 1 of the study. A woman is considered to not be of childbearing potential if she is postmenopausal or has undergone hysterectomy and/or bilateral oophorectomy. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug Arm<br>Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month | Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]<br>* Anti-VEGF injection<br>|
| Other: Control Arm<br>Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment) | Drug: Ranibizumab<br>* Anti-VEGF standard of care injection<br>* Other names: bevacizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of study drug measured by change in best corrected visual acuity | Change in Snellen equivalent letters from baseline to end of study | 18 months | 
| Efficacy of study measured by change in central foveal thickness | Change in microns of macular thickness as assessed by Optical Coherence Tomography (OCT) from baseline to end of study | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of study drug as measured by number of adverse events related to study drug | adverse events, serious adverse events reported causal to drug | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascularization