Ziv-aflibercept Efficacy in Better Regulating AMD

NCT ID: NCT03423823

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-07
• Study Completion Date: 2020-06-26

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).

Conditions

Wet Macular Degeneration; Wet Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Drug Arm

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

Group Type: EXPERIMENTAL

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Intervention Type: DRUG

Anti-VEGF injection

Control Arm

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

Group Type: OTHER

Ranibizumab

Intervention Type: DRUG

Anti-VEGF standard of care injection

Interventions

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Anti-VEGF injection

Intervention Type: DRUG

Ranibizumab

Anti-VEGF standard of care injection

Intervention Type: DRUG

Other Intervention Names

aflibercept; bevacizumab

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kapil Kapoor

OTHER

Sponsor Role: lead

Responsible Party

Kapil Kapoor

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wagner Macula & Retina Center

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

ZA511293

Identifier Type: -

Identifier Source: org_study_id