Clinical trial NCT03423823: Ziv-aflibercept Efficacy in Better Regulating AMD
Official title: An Active-treatment Study of the Efficacy of Ziv-aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wet Macular Degeneration
Wet Age-related Macular Degeneration
Keywords: Neovascularization
Lead sponsor: Wagner Macula & Retina Center
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Efficacy of study drug measured by change in best corrected visual acuity
timeFrame: 18 months
measure: Efficacy of study measured by change in central foveal thickness
timeFrame: 18 months
Secondary outcomes:
measure: Safety of study drug as measured by number of adverse events related to study drug
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Virginia Beach
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
Study officials:
References: