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OpenTrials
Completed

NCT Number: NCT03423823

Ziv-aflibercept Efficacy in Better Regulating AMD

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).

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Key information

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wagner Macula & Retina Center

Virginia Beach, Virginia, 23454, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Drug

Anti-VEGF injection

ranibizumab

Drug

Anti-VEGF standard of care injection

Other names: aflibercept, bevacizumab

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kapil Kapoor

Other

Registry information

Official study title

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

Acronym: ZEBRA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2018
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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