Ziv-aflibercept Efficacy in Better Regulating AMD
Phase 2
Completed
- Conditions
- Wet Age-related Macular DegenerationWet Macular Degeneration
- Interventions
- Registration Number
- NCT03423823
- Lead Sponsor
- Kapil Kapoor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Drug Arm Ziv-Aflibercept 25 MG/ML [Zaltrap] Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month Control Arm Ranibizumab Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Wagner Macula & Retina Center
🇺🇸Virginia Beach, Virginia, United States