Ziv-aflibercept Efficacy in Better Regulating AMD

• Status: Completed
• Trial end date: 2020-06-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kapil Kapoor
• Treatments: Aflibercept; Bevacizumab; Ranibizumab

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.