Ziv-aflibercept Efficacy in Better Regulating AMD

NCT03423823 | Completed Phase 2 FDA Drug

• 1 other identifier: ZA511293
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

Neovascularization

Outcome Measures

Primary Outcomes (2)

• Efficacy of study drug measured by change in best corrected visual acuity

  Change in Snellen equivalent letters from baseline to end of study

  18 months

• Efficacy of study measured by change in central foveal thickness

  Change in microns of macular thickness as assessed by Optical Coherence Tomography ("OCT") from baseline to end of study

  18 months

Secondary Outcomes (1)

• Safety of study drug as measured by number of adverse events related to study drug

  2.5 years

Study Arms (2)

Study Drug Arm

EXPERIMENTAL

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

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

Control Arm

OTHER

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

Drug: Ranibizumab

Interventions

Ziv-Aflibercept 25 MG/ML [Zaltrap] DRUG

Anti-VEGF injection

Study Drug Arm

Ranibizumab DRUG

Anti-VEGF standard of care injection

Also known as: aflibercept, bevacizumab

Control Arm

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kapil Kapoor: lead

Study Sites (1)

Wagner Macula & Retina Center

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Wet Macular Degeneration; Neovascularization, Pathologic

Interventions

aflibercept; Ranibizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 6, 2018
• Study Start: July 7, 2017
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)