A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kodiak Sciences Inc
This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent prior to participation in the study.
Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
You may not be if
CNV secondary to other causes in the Study Eye.
Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
Active ocular or periocular infection or inflammation.
Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
Uncontrolled glaucoma in the Study Eye.
Women who are pregnant or lactating or intending to become pregnant during the study.
Stroke or myocardial infarction in the 6-month period prior to Day 1.
Uncontrolled blood pressure defined as a systolic value \> 180 mmHg or diastolic value ≥100 mmHg while at rest.
History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
Clareo Health | A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
