Trial | NCT03423823  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    62
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 Started
Jul 07
2017
Primary Completion
Jun 26
2020
Study Completion
Jun 26
2020
Last Update
Oct 06
2020

Drug Ziv-Aflibercept 25 MG/ML [Zaltrap]

Anti-VEGF injection

Drug Ranibizumab

Anti-VEGF standard of care injection

  • Other names: aflibercept, bevacizumab

Study Drug Arm Experimental

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

Control Arm Other

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

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.
No Results Posted