Ziv-aflibercept Efficacy in Better Regulating AMD (ZEBRA)

Kapil Kapoor

Status and phase: Completed; Phase 2

Conditions: Wet Age-related Macular Degeneration; Wet Macular Degeneration

Treatments: Drug: Ranibizumab; Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]

Study type: Interventional

Funder types: Other

Identifiers

NCT03423823

ZA511293

Details and patient eligibility

About

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).

Enrollment: 62 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Study Drug Arm

Experimental group

Description:

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

Treatment:

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

Control Arm

Other group

Description:

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

Treatment:

Drug: Ranibizumab