Status:
COMPLETED
Ziv-aflibercept Efficacy in Better Regulating AMD
Lead Sponsor:
Kapil Kapoor
Conditions:
Wet Macular Degeneration
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50-99 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03423823
Start Date
July 7 2017
End Date
June 26 2020
Last Update
October 6 2020
Active Locations (1)
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1
Wagner Macula & Retina Center
Virginia Beach, Virginia, United States, 23454