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Wet Macular DegenerationPhase 2ZEBRANCT03423823

Ziv-aflibercept Efficacy in Better Regulating AMD

A Phase 2 study testing Ziv-Aflibercept 25 MG/ML [Zaltrap] and Ranibizumab in people with Wet Macular Degeneration and Wet Age-related Macular Degeneration, run by Kapil Kapoor at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
Ziv-Aflibercept 25 MG/ML [Zaltrap] and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
7 Jul 2017to 26 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wagner Macula & Retina Center

    Virginia Beach, Virginia, 23454

Other trials in United States

About this study

Official title: 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).

Being tested
Ziv-Aflibercept 25 MG/ML [Zaltrap], Ranibizumab
Keywords
Neovascularization
Medical subject headings
Wet Macular Degeneration, Neovascularization, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ziv-Aflibercept 25 MG/ML [Zaltrap]Drug

    Anti-VEGF injection

  • RanibizumabDrug

    Also called aflibercept, bevacizumab

    Anti-VEGF standard of care injection

Study groups in NCT03423823
Study groupRoleWhat they receive
Study Drug ArmExperimentalReceiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month
Receives: Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]
Control ArmOtherReceiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment)
Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in Snellen equivalent letters from baseline to end of study

    Measured: 18 months

  2. 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

    Measured: 18 months

Secondary outcomes (1)

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

    adverse events, serious adverse events reported causal to drug

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2018
  2. Study start7 Jul 2017
  3. Primary completion26 Jun 2020
  4. Study completion26 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03423823
Sponsor's protocol ID
ZA511293
Acronym
ZEBRA
Status last verified
Oct 2020
First submitted
23 Jan 2018
Last updated
6 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ziv-Aflibercept 25 MG/ML [Zaltrap] and Ranibizumab in people with Wet Macular Degeneration and Wet Age-related Macular Degeneration, run by Kapil Kapoor at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of study drug measured by change in best corrected visual acuity (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03423823.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.

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