Kodiak DAYLIGHT Study - Wet AMD

A Study of Intravitreal KSI-301 Compared With Aflibercept in Participants With Neovascular (Wet) AMD - DAYLIGHT

Study Description:

Detailed Description:

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD).  Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.

The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time.

For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.

Inclusion Criteria: 

• 50 years and older.
• Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
• BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
• Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
• Other protocol-specified inclusion criteria may apply 

Exclusion Criteria:

• BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
• Active or suspected ocular or periocular infection or inflammation.
• CNV secondary to other causes in the Study Eye.
• Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.
• Uncontrolled glaucoma in the Study Eye.
• Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
• Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
• Women who are pregnant or lactating or intending to become pregnant during the study.
• Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
• 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.
• Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest.
• Other protocol-specified exclusion criteria may apply.