Ziv-aflibercept Efficacy in Better Regulating AMD (ZEBRA)

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

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).

Study Overview

• Status: Completed
• Conditions: Wet Macular Degeneration; Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]; Drug: Ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Wagner Macula & Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kapil Kapoor

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Neovascularization
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: ZA511293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No