KODIAK: A phase II study in patients with the exudative form of AMD 18/11/2020
KODIAK KSL-CL-102: A phase II, prospective, randomised study with double masking of two groups. It assesses the efficacy and safety of repeated intravitreal administration of KSI-301 5mg compared to aflibercept 2mg in patients with the exudative form of age-related macular degeneration (AMD).
Main inclusion criteria
Patients of 50 and above with active choroidal neovascularisation secondary to AMD and who have not received any previous treatment in the study eye.
Visual acuity should be between 80 and 25 letters (approximate Snellen equivalent of 20/25 to 20/320).
To demonstrate that treatment with KSI-301 5mg is not inferior to using aflibercept 2mg with respect to the change in visual acuity from the baseline visit to the one made after the first year of treatment.
Vascular endothelial growth factor (VEGF) is a glycoprotein with a trophic and proliferative role, promoting the growth of new filtering and abnormal blood vessels in the retina in patients with exudative AMD.
KSI-301 is a new molecular entity (NME) formed by an antibody biopolymer conjugate and is responsible for the inhibition of the VEGF. Therefore, KSI-301 acts primarily as an antiangiogenic and anti-permeabilising agent, which brings a clinical benefit in VEGF-mediated disorders, such as exudative AMD.
This NME is designed to improve visual acuity with an extended intraocular half-life and longer treatment intervals in comparison to other intravitreal medications.
Previous studies in humans have shown that a single administration of 1.25mg, 2.5mg or 5mg of KSI-301 was safe and tolerable in subjects with diabetic macular oedema (DMO). Based on the observed tolerability and activity of the single dose, the highest dose of KSI-301 tested in the Phase 1 study (5mg) was selected for this Phase 2 study on exudative AMD.
The duration of this trial is two years.