Ziv-aflibercept Efficacy in Better Regulating AMD
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - 99 |
| Updated: | 2/8/2018 |
| Start Date: | July 7, 2017 |
| End Date: | July 7, 2020 |
| Contact: | Kapil Kapoor, MD |
| Email: | research@wagnerretina.com |
| Phone: | 7574814400 |
An Active-treatment Study of the Efficacy of Ziv-aflibercept in Patients With Neovascular Age-Related Macular Degeneration
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).
of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control
anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab,
or aflibercept).
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.
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