A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (DAYLIGHT)

Kodiak Sciences

Status and phase: Completed; Phase 3

Conditions: Wet Age-related Macular Degeneration

Treatments: Drug: KSI-301; Drug: Aflibercept; Other: Sham Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04964089

KS301P107

Details and patient eligibility

About

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Full 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)

The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time

Enrollment: 557 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent prior to participation in the study.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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557 participants in 2 patient groups

KSI-301 (Treatment Group A)

Experimental group

Description:

Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.

Treatment:

Drug: KSI-301

Aflibercept (Treatment Group B)

Active Comparator group

Description:

Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.

Treatment:

Other: Sham Procedure

Drug: Aflibercept