ZEBRA: Ziv-aflibercept Efficacy in Better Regulating AMD
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
|
Outcome Measures
Primary Outcome Measures
- Efficacy of study drug measured by change in best corrected visual acuity [18 months]
Change in Snellen equivalent letters from baseline to end of study
- Efficacy of study measured by change in central foveal thickness [18 months]
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 [2.5 years]
adverse events, serious adverse events reported causal to drug
Eligibility Criteria
Criteria
Inclusion Criteria:
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Are age 50-99
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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.
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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.
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Are willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments.
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Have received an intravitreal injection of one of the drugs listed above within 120 days of Day 1 of the trial.
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Both males and females will be enrolled.
Exclusion Criteria:
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Active intraocular inflammation or infection
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History of vitreous hemorrhage within three months prior to Day 1 of the study
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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
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History of stroke within the last three months prior to Day 1 of the study
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History of myocardial infarction within the last three months prior to Day 1 of the study
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Undergone intraocular surgery or laser treatments within the last three months,
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Significant Epiretinal Membrane ("ERM") or Vitreomacular Traction ("VMT") causing distortion of macular anatomy
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No use of ocular corticosteroids within the last six months and no use of systemic corticosteroids at a dose of >10 mg/day
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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
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Inability to comply with study or follow-up procedures
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Women who may become pregnant or lactating or intend to become pregnant during the study
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Wagner Macula & Retina Center | Virginia Beach | Virginia | United States | 23454 |
Sponsors and Collaborators
- Kapil Kapoor
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZA511293