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Ziv-aflibercept Efficacy in Better Regulating AMD (ZEBRA)

Primary Purpose

Wet Macular Degeneration, Wet Age-related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Ranibizumab

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring Neovascularization

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wagner Macula & Retina Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study Drug Arm

Control Arm

Arm Description

Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month

Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment)

Outcomes

Primary Outcome Measures

Efficacy of study drug measured by change in best corrected visual acuity

Change in Snellen equivalent letters from baseline to end of study

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

Secondary Outcome Measures

Safety of study drug as measured by number of adverse events related to study drug

adverse events, serious adverse events reported causal to drug

Full Information

NCT ID

NCT03423823

First Posted

January 23, 2018

Last Updated

October 5, 2020

Sponsor

Kapil Kapoor

1. Study Identification

Unique Protocol Identification Number

NCT03423823

Brief Title

Ziv-aflibercept Efficacy in Better Regulating AMD

Acronym

ZEBRA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 7, 2017 (Actual)

Primary Completion Date

June 26, 2020 (Actual)

Study Completion Date

June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kapil Kapoor

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wet Macular Degeneration, Wet Age-related Macular Degeneration

Keywords

Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Drug Arm

Arm Type

Experimental

Arm Description

Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month

Arm Title

Control Arm

Arm Type

Other

Arm Description

Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment)

Intervention Type

Drug

Intervention Name(s)

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Intervention Description

Anti-VEGF injection

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

aflibercept, bevacizumab

Intervention Description

Anti-VEGF standard of care injection

Primary Outcome Measure Information:

Title

Efficacy of study drug measured by change in best corrected visual acuity

Description

Change in Snellen equivalent letters from baseline to end of study

Time Frame

18 months

Title

Efficacy of study measured by change in central foveal thickness

Description

Change in microns of macular thickness as assessed by Optical Coherence Tomography ("OCT") from baseline to end of study

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Safety of study drug as measured by number of adverse events related to study drug

Description

adverse events, serious adverse events reported causal to drug

Time Frame

2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Wagner Macula & Retina Center

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Ziv-aflibercept Efficacy in Better Regulating AMD

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