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Ziv-aflibercept Efficacy in Better Regulating AMD (ZEBRA)

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ClinicalTrials.gov Identifier: NCT03423823
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kapil Kapoor, Wagner Macula & Retina Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Wet Age-related Macular Degeneration Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap] Drug: Ranibizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Active-treatment Study of the Efficacy of Ziv-aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : December 7, 2018
Estimated Study Completion Date : July 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Drug Arm
Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month
Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]
Anti-VEGF injection

Control Arm
Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment)
Drug: Ranibizumab
Anti-VEGF standard of care injection
Other Names:
  • aflibercept
  • bevacizumab




Primary Outcome Measures :
  1. Efficacy of study drug measured by change in best corrected visual acuity [ Time Frame: 18 months ]
    Change in Snellen equivalent letters from baseline to end of study

  2. Efficacy of study measured by change in central foveal thickness [ Time Frame: 18 months ]
    Change in microns of macular thickness as assessed by Optical Coherence Tomography ("OCT") from baseline to end of study


Secondary Outcome Measures :
  1. Safety of study drug as measured by number of adverse events related to study drug [ Time Frame: 2.5 years ]
    adverse events, serious adverse events reported causal to drug



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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423823


Contacts
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Contact: Kapil Kapoor, MD 7574814400 research@wagnerretina.com

Locations
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United States, Virginia
Wagner Macula & Retina Center Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Principal Investigator, MD    757-481-4400    research@wagnerretina.com   
Sponsors and Collaborators
Kapil Kapoor

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Responsible Party: Kapil Kapoor, Principal Investigator, Wagner Macula & Retina Center
ClinicalTrials.gov Identifier: NCT03423823     History of Changes
Other Study ID Numbers: ZA511293
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kapil Kapoor, Wagner Macula & Retina Center:
Neovascularization

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors