Wet Age-related Macular Degeneration, Wet Macular Degeneration
Conditions
Keywords
Neovascularization
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).
Interventions
Anti-VEGF injection
DRUGRanibizumab
Anti-VEGF standard of care injection
Sponsors
Kapil Kapoor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of study drug measured by change in best corrected visual acuity | 18 months | Change in Snellen equivalent letters from baseline to end of study |
| Efficacy of study measured by change in central foveal thickness | 18 months | Change in microns of macular thickness as assessed by Optical Coherence Tomography (OCT) from baseline to end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of study drug as measured by number of adverse events related to study drug | 2.5 years | adverse events, serious adverse events reported causal to drug |
Countries
United States
Outcome results
None listed